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PubMed1983

Ultrastructural effects of topical timolol on the rabbit cornea. Outcome alone and in conjunction with a gas permeable contact lens.

Corneal epithelial erosions developed in two patients wearing gas permeable contact lenses (Boston) soon after commencing topical timolol maleate therapy. This prompted the following investigation. Forty rabbit corneas were examined by scanning and transmission electron microscopy after treatment for one month with one of the following: timolol ophthalmic solution, preservative-free timolol, contact lens, contact lens and timolol, contact lens and preservative-free timolol, contact lens and saline, or no treatment. Corneas treated with either timolol or contact lens alone showed mild to moderate edema or degeneration of epithelial and endothelial cells. However, the combined use of a contact lens and timolol produced marked alterations in both the corneal epithelium and endothelium.

Administration, Topical↗
PubMed1984

Timolol v guanethidine-epinephrine formulations in the treatment of glaucoma. An open clinical trial.

Patients with glaucoma received either 3% guanethidine-0.5% epinephrine (20 patients) or 1% guanethidine-0.2% epinephrine (20 patients) and then 0.5% timolol maleate. The fall in intraocular pressure during 3% guanethidine-0.5% epinephrine therapy (10.1 mm Hg [34.4%] reduction) was higher than during timolol therapy (7.5 mm Hg [25.5%] reduction) and the response to 1% guanethidine-0.2% epinephrine therapy (7.9 mm Hg [29%] reduction) equaled the response to timolol (7.3 mm Hg [26.8%] reduction). During 3% guanethidine-0.5% epinephrine therapy, 24 (67.7%) of 36 eyes had an average IOP lower than 22 mm Hg, compared with 16 (44.4%) of 36 timolol-treated eyes. With 1% guanethidine-0.2% epinephrine, IOP in 27 (73%) of 37 eyes was less than 22 mm Hg v 23 (62.2%) of 37 timolol-treated eyes. Both guanethidine-epinephrine formulations increased outflow facility. Since timolol produced few side effects, it appears to be the therapy of choice. However, in patients who do not respond sufficiently to timolol, both guanethidine-epinephrine formulations are potent alternatives.

Adult↗
PubMed1992

Timolol-pilocarpine fixed-ratio combinations in the treatment of chronic open angle glaucoma. A controlled multicenter study of 48 weeks. Scandinavian Timpilo Study Group.

The effect of the fixed combination of 0.5% timolol maleate with 2% pilocarpine hydrochloride given twice a day and 0.5% timolol with 4% pilocarpine given twice a day was tested in a long-term, multicenter study. A total of 360 patients with open angle glaucoma were included; they were defined as those who had intraocular pressure greater than 21 mm Hg while receiving single, topical antiglaucoma therapy. Primarily, the purpose of the study was to investigate the efficacy of 0.5% timolol-2% pilocarpine, and second, to see to what extent an increase in concentration to 0.5% timolol-4% pilocarpine would further lower intraocular pressure in those patients with an intraocular pressure of greater than 21 mm Hg while taking 0.5% timolol-2% pilocarpine. The cohort of 228 patients went through the examinations for a total of 48 weeks. A mean decrease in intraocular pressure from 24.7 +/- 2.8 to 21.0 +/- 3.8 mm Hg was observed. During the trial, approximately 33% of the patients required an increase in concentration to 0.5% timolol-4% pilocarpine after the week 8 examination. At week 12, in those using 0.5% timolol-4% pilocarpine, an additional 2.2 mm Hg lowering of intraocular pressure was observed. Side effects were minor and temporary and did not necessitate withdrawal from the study.

Adult↗
PubMed1995

The efficacy of apraclonidine as an adjunct to timolol therapy. Apraclonidine Adjunctive Therapy Study Group.

OBJECTIVE: To compare the intraocular pressure (IOP) lowering efficacy of 0.5% and 1.0% apraclonidine hydrochloride when used adjunctively with 0.5% timolol maleate in 129 patients. DESIGN: A multicenter, randomized, double-masked clinical trial. Adult patients of either sex diagnosed as having either open-angle glaucoma or ocular hypertension were enrolled in the study. Patients using only 0.5% timolol maleate twice daily for at least 4 weeks and who had 8 AM IOPs of at least 22 mm Hg and no greater than 30 mm Hg 12 hours after dosing were eligible for the study. After 8 AM baseline IOPs were obtained while patients were taking timolol only, they were then randomized to receive either 0.5% or 1.0% apraclonidine twice daily in addition to their timolol. Intraocular pressures were measured at 8 AM (before morning dosing) and at 11 AM (3 hours after dosing) on days 14 and 90 and at 8 AM only on day 45. RESULTS: Both concentrations of apraclonidine produced significant IOP reductions from baseline at all visits (P < .001). At 8 AM, after the nighttime dose, the additional mean IOP reduction from the timolol baseline ranged from 2.5 to 3.3 mm Hg (10.3% to 13.6% reduction, respectively). At 11 AM, 3 hours after the morning dose, the additional IOP reduction from the timolol baseline ranged from 4.7 to 5.2 mm Hg (20.0% to 21.7%, respectively). No difference in IOP reduction was observed between the 0.5% and 1.0% apraclonidine concentrations and no loss of IOP efficacy was observed for either concentration for the duration of the study. Sensitivity to 0.5% and 1.0% apraclonidine was observed in nine (13.8%) and 13 (20.3%) patients, respectively. Overall, therapy was discontinued owing to ocular or nonocular side effects with 0.5% and 1.0% apraclonidine in 14 (21.5%) and 16 (25%) patients, respectively. CONCLUSIONS: We believe that 0.5% apraclonidine is equally effective as 1.0% apraclonidine when used twice daily as the first adjunctive drug to timolol. The drug effect is maintained for at least 90 days.

Adrenergic alpha-Agonists↗
PubMed1996

A comparison of latanoprost and timolol in primary open-angle glaucoma and ocular hypertension. A 12-week study.

OBJECTIVE: To evaluate the intraocular pressure (IOP)-reducing effect and the side effects of latanoprost (PhXA41), a new phenyl-substituted prostaglandin F2 alpha-isopropyl ester analogue, in patients with elevated IOP, using timolol maleate as the reference drug. METHODS: A total of 184 patients with primary open-angle glaucoma or ocular hypertension at 35 medical centers participated in this randomized double-masked study. The patients were randomized to receive either 0.005% latanoprost once daily or 0.5% timolol maleate twice daily, for a period of 12 weeks. Intraocular pressure was measured 24 hours after the administration of timolol, at 2, 4, 8, and 12 weeks of treatment. RESULTS: Latanoprost reduced IOP at the end of 12 weeks by 6.2 +/- 2.7 mm Hg (mean +/- SD) (26.8%), while timolol reduced IOP by 4.4 +/- 2.3 mm Hg (19.9%). At all visits latanoprost reduced IOP significantly more than timolol did. The main ocular side effects observed in both groups were conjunctival hyperemia and smarting. The main systemic side effect was a reduced pulse rate, which occurred in patients treated with timolol. CONCLUSIONS: The results of this study demonstrated that 0.005% latanoprost taken once daily is well tolerated and more effective in reducing IOP than 0.5% timolol taken twice daily. Thus, latanoprost may become an important choice for the medical treatment of glaucoma.

Adrenergic beta-Antagonists↗
PubMed1993

Comparisons of beta-adrenergic blocking properties of S- and R-timolol in humans.

In animals, the R-enantiomer of timolol causes a significant reduction in intraocular pressure but had only 1/80 the activity of the S-enantiomer at extraocular receptors. The beta 1- and beta 2-adrenoceptor blocking properties of orally administered R- and S-timolol were compared in a double-blind placebo controlled trial in two groups of healthy men. Each subject in group A (n = 6) received placebo, 1 and 3 mg S-timolol and 25 and 75 mg R-timolol in random order, group B (n = 5) received placebo, 0.5, and 1 mg S-timolol and 3 and 10 mg R-timolol. In both groups, R- and S-timolol comparably inhibited isoproterenol-induced increases in heart rate (P < .05), forearm blood flow (P < .05, except at 3 micrograms/minute of isoproterenol after the R-doses in group B), and finger tremor (P < .05) in comparison with placebo. The findings for the R-enantiomer in this study were unexpected based on the animal studies and previous studies that demonstrated marked differences in beta blocking effects of other beta-blockers in which the R-enantiomers were less inhibitory.

Adrenergic beta-Antagonists↗
PubMed2000

Timolol lowers intraocular pressure but does not inhibit the development of experimental myopia in chick.

Reports of intraocular pressure (IOP) being higher in myopes than emmetropes and of myopes being over-represented in glaucoma statistics, are consistent with a role of IOP in the excessive eye growth typically associated with myopia. We tested the hypothesis, based on these observations, that ocular hypotensive drugs would slow myopia progression using the chick as an animal model and timolol as an example of such a drug. To induce myopia, chicks (n = 56) were fitted with either monocular translucent diffusers or -15 D spectacle lenses from day 8. The drug treatment protocol comprised topical applications of 0.4% benoxinate, a local anaesthetic (to improve drug absorption), followed either by 0.5% timolol or distilled water (control), either daily (1000 hr) or twice daily (1000, 1600 hr). Refractive errors and ocular dimensions were measured on days 12 and 17. We also verified the ocular hypotensive effect of timolol in both normal (n = 8) and myopic (n = 12 diffusers; n = 12-15 D lenses) chicks. Here, we took baseline IOP measurements, instilled timolol and then monitored IOP over a further 5-9 hr. We found no difference in the amount of myopia produced in the timolol and control groups at either measurement time point (e.g. day 17, once per day application, diffusers: -26.9 +/- 3.3 D vs -22.7 +/- 9.1 D; lenses: -14.9 +/- 3.8 D vs -14.9 +/- 3.6 D). This was in spite of the fact that timolol did lower IOP in both normal and myopic chicks (27 and 18% reduction, respectively) While timolol does have an ocular hypotensive effect in the chick, it does not inhibit the development of myopia in this animal model.

Analysis of Variance↗
PubMedDate not supplied

Ocular hypotensive effect of sublingual administration of timolol.

PURPOSE: A randomized clinical, trial to assess ocular hypotensive effect of sublingual administration of timolol was performed. PATIENTS AND METHODS: Seventeen (9 male, 8 female; age range 45 to 68 years) with bilateral ocular hypertension were selected for the study. Each patient was evaluated with regard to IOP, arterial blood pressure and heart rate before and after each of the following experimental treatment: unilateral ocular administration of 20 microliters of 0.5% timolol solution; sublingual administration of 20 microliters of 0.5% timolol solution; unilateral ocular administration of 20 microliters of saline solution (placebo); sublingual administration of 20 microliters of saline solution (placebo). The sequence of the treatments and the eye topically treated were randomly chosen. At least four weeks wash-out elapsed between each experimental treatment. RESULTS: Our results showed that sublingual administration of timolol was able to induce a bilateral significant reduction of the IOP. This reduction was not statistically different from that obtained in the eye treated with timolol. A significantly greater reduction of the IOP was obtained by sublingual timolol than in the contralateral eye after unilateral topical administration of timolol solution. No significant modification of arterial blood pressure and heart rate were evidenced after the treatment. CONCLUSIONS: Sublingual administration seems to be a new interesting way for reducing the IOP. Long term studies are required in order to test efficacy and safety of this new treatment.

Administration, Sublingual↗
PubMedDate not supplied

Efficacy of latanoprost and timolol maleate in black and white patients.

The purpose of this study was to assess the efficacy of latanoprost 0.005% and timolol maleate 0.5% in black and white patients with elevated intraocular pressure (IOP). This double-masked, randomized, 2-period crossover study included 39 eyes in 22 patients with primary open-angle glaucoma or ocular hypertension. After a 2- to 4-week washout period, patients were randomly assigned to receive either vehicle placebo in the morning and latanoprost in the evening or timolol maleate twice daily for 6 weeks. Then, after a 4-week washout period, patients received the opposing treatment for 6 weeks. Both latanoprost and timolol maleate significantly lowered IOP from baseline in both black and white patients. Latanoprost treatment was associated with lower mean IOP compared with timolol treatment in black patients (P = .013 at 8 AM, P = .19 at 10 AM). At 10 AM at the end of the treatment period, the mean +/- SD change from baseline IOP in black patients receiving latanoprost was significantly greater than that of white patients (-10.2 +/- 7.0 and -5.9 +/- 2.5 mm Hg, respectively; P = .042). The mean +/- SD change from baseline IOPs in black patients was not significantly different from that in white patients at 8 AM at the end of the treatment period for the latanoprost group and at 8 AM and 10 AM at the end of the treatment period for the timolol maleate group. In white patients, the change from baseline IOP in light (grade 1) irises was not significantly different from dark (grade 5) irises after treatment with either latanoprost or timolol maleate. In summary, intraocular pressure after treatment with latanoprost was lower than that after timolol treatment in black patients with primary open-angle glaucoma or ocular hypertension, and at 1 of 2 timepoints, latanoprost caused a significantly greater reduction of IOP in black patients than in white patients.

Aged↗
PubMed2004

A 6-month randomized clinical trial of bimatoprost 0.03% versus the association of timolol 0.5% and latanoprost 0.005% in glaucomatous patients.

BACKGROUND: New effective hypotensive agents have been recently introduced into clinical practice, but often more than one drug has to be used to prevent further visual field loss. The aim of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of bimatoprost 0.03% compared with the association of timolol 0.5% and latanoprost 0.005% in open-angle glaucoma patients. METHODS: In this 6-month, prospective, parallel, randomised, investigator-masked clinical trial, 61 glaucomatous patients treated with timolol 0.5% twice in both eyes were enrolled. The timolol 0.5% was replaced by bimatoprost 0.03% once daily (group I) or by latanoprost 0.005% plus timolol 0.5% (group II). IOP measurements were performed at the baseline visit and at days 15, 30, 60, 90, 120 and 180. Digital colour photography was used to evaluate topical side effects. RESULTS: Fifty-six of the 61 patients were included for the intent-to-treat analysis (28 in group I and 28 in group II). Baseline mean IOP was similar in the two groups (p=0.5). Both treatments lowered the mean IOP at every visit significantly compared with the baseline (p<0.01). Comparing the IOP reductions obtained by the two treatments, no significant differences were found at any time during the study. Conjunctival hyperaemia, skin pigmentation and eyelash growth in group I and headache in group II were the most common side effects observed during the study. CONCLUSIONS: Bimatoprost and the association of latanoprost plus timolol were equally effective in lowering the IOP in glaucomatous patients previously treated with timolol. Latanoprost plus timolol showed a better ocular safety profile.

Adult↗
PubMed1998

Comparison of two fixed combinations of latanoprost and timolol in open-angle glaucoma.

OBJECTIVE: To compare the intraocular pressure (IOP)-reducing effect of the fixed combinations of timolol 0.5% and latanoprost 0.001% or 0.005% after 4 weeks' treatment. DESIGN: Following a 1-week run-in period on timolol 0.5% once daily, 139 patients were randomized to once-daily treatment with a fixed combination of timolol 0.5% and latanoprost 0.001% (comb. 10) or latanoprost 0.005% (comp. 50) or to the individual monotherapies. The IOP was measured at inclusion and at 8 a.m., noon and 4 p.m. on days 1, 7 and 28. RESULTS: Comb. 10, comb. 50, latanoprost and timolol reduced IOP by 3.7, 6.1, 4.9 and 2.1 mmHg, respectively, from a baseline mean diurnal IOP (+/- SEM) of 24.8 +/- 0.5, 24.1 +/- 0.4, 25.2 +/- 1.2 and 24.8 +/- 0.9 mmHg, respectively. The difference in IOP reduction was significant between comb. 50 and comb. 10 (P < 0.001), latanoprost (P = 0.046) and timolol (P < 0.001) in favor of comb. 50. There was also a significant difference between latanoprost and timolol (P = 0.007), in favor of latanoprost. All treatments were generally well tolerated. CONCLUSION: This study indicates that a fixed combination of latanoprost 0.005% and timolol 0.5% could be useful in the treatment of glaucoma.

Adult↗
PubMed2006

Effect and mechanism of betaxolol and timolol on vascular relaxation in isolated rabbit ciliary artery.

PURPOSE: In order to clarify the vasodilatory mechanism of betaxolol and timolol, we studied the effects of these drugs in isolated rabbit ciliary arteries. METHODS: Rabbit ciliary artery specimens were mounted in a double myograph system, and betaxolol, timolol, or another agent was introduced into the organ chamber. The mechanical response of the arteries was studied using an isometric tension recording method. The intracellular free calcium concentration [Ca2+]i was also measured using fluorescence photometry. RESULTS: Betaxolol and timolol induced dose-dependent relaxation in the rabbit ciliary arteries precontracted by high-K+ Krebs solution. The minimum concentrations required to cause relaxation were 10 microM of betaxolol, and 30 microM of timolol. At the maximum concentration of 1 mM, betaxolol induced almost complete relaxation of the ciliary arteries, whereas timolol induced approximately 70% relaxation. These actions were not inhibited by pretreatment with 100 microM NG-nitro-l-arginine methylester (L-NAME), a nitric oxide synthase inhibitor, or by denudation of the vascular endothelium. However, 300 microM of betaxolol or timolol decreased the [Ca2+]i of the vascular smooth muscle, an action similar to that of diltiazem, a typical L-type voltage calcium-channel blocker. CONCLUSIONS: Betaxolol, a selective beta1-adrenoceptor antagonist, and timolol, a nonselective beta-adrenoceptor antagonist, both frequently used in the medical management of glaucoma, decrease [Ca2+]i by acting as Ca2+ channel blockers, thus causing relaxation of isolated rabbit ciliary artery.

Adrenergic beta-Antagonists↗
PubMed1989

Microemulsions as topical delivery vehicles: ocular administration of timolol.

The topical administration of timolol as an ion-pair with octanoate was achieved by use of an oil-in-water microemulsion containing lecithin as a surfactant. The microemulsion, a solution of the ion-pair and a solution of timolol alone were instilled in the conjunctival sac of rabbits. A rapid method for the separation and determination of timolol in aqueous humour by HPTLC was used. The bioavailability of timolol from the microemulsion and the ion-pair solution was higher than that obtained from timolol alone. The areas under the curve for timolol in aqueous humour after administration of the microemulsion and the ion-pair solution were 3.5 and 4.2 times higher, respectively, than that observed after the administration of timolol alone.

Absorption↗
PubMed2005

Ocular release of timolol from molecularly imprinted soft contact lenses.

The aim of this study was to evaluate "in vivo" the usefulness of molecular imprinting technology to obtain therapeutic soft contact lenses capable of prolonging the permanence of timolol in the precorneal area, compared to conventional contact lenses and eyedrops. Soft contact lenses (diameter 14 mm, center thickness 0.08 mm) consisted of N,N-diethylacrylamide (DEAA; main component of the matrix), methacrylic acid (MAA; functional monomer) and ethylene glycol dimethacrylate (EGDMA; cross-linker) were prepared by the conventional methodology (non-imprinted) or by applying a molecular imprinting technique using timolol as the template (imprinted ones). After washing and reloading, timolol release studies carried out in rabbits showed that the soft contact lenses made by the molecular imprinting method (34 microg dose) provided measurable timolol concentrations in the tear fluid for 2.0- and 3.0-fold longer than the non-imprinted contact lenses (21 microg dose) and eyedrops (doses of 34 and 125 microg), respectively. Furthermore, the area under the timolol concentration-time curve (AUC) was 3.3- and 8.7-fold greater for imprinted contact lenses than non-imprinted contact lenses and eyedrops, respectively. The timolol concentration of the eyedrops did not affect the precorneal residence time of drug significantly. On the other hand, timolol loading capacity of the contact lenses was improved by the molecular imprinting method; the sustaining of the drug levels in the tear fluid being proportional to the loading capacity of the contact lenses. These results indicate that imprinted soft contact lenses are promising drug devices able to provide greater and more sustained drug concentrations in tear fluid with lower doses than conventional eyedrops.

Absorption↗
PubMed2006

A randomized, investigator-masked, 4-week study comparing timolol maleate 0.5%, brinzolamide 1%, and brimonidine tartrate 0.2% as adjunctive therapies to travoprost 0.004% in adults with primary open-angle glaucoma or ocular hypertension.

OBJECTIVE: The objective of this study was to assess the hypotensive efficacy of timolol maleate 0.5%, brinzolamide 1%, or brimonidine tartrate 0.2% ophthalmic solution, administered in conjunction with travoprost 0.004%, in patients with primary open-angle laucoma (OAG) or ocular hypertension (OHT) whose intraocular pressure (IOP) did not meet the treatment target using travoprost 0.004% monotherapy. METHODS: This was a randomized, comparative, investigator-masked study. Patients with OAG or OHT treated with travoprost 0.004% monotherapy were randomized to receive 1 of the 3 adjunctive therapies (timolol maleate 0.5%, brinzolamide 1%, or brimonidine tartrate 0.2%), 1 drop BID in each randomized eye, in addition to 1 drop QD of travoprost for a period of 4 weeks. IOP was measured on days 0 (travoprost 0.004%) and 28 (travoprost 0.004% and adjunctive treatment). Adverse events were monitored on days 0 and 28 by patient interview. RESULTS: Twenty-nine patients with OAG (46 eyes) and 3 patients with OHT (6 eyes), with a total of 52 eligible eyes, completed the study; 28 eyes were from male patients and 24 were from female patients. In addition to continuing travoprost treatment, 20 eyes received timolol, 16 eyes received brinzolamide, and 16 eyes were treated with brimonidine. There were no significant differences among the groups in the mean (SD) IOP at baseline on day 0 (19.0 [4.1], 17.2 [3.5], and 17.0 [3.1] mm Hg, respectively; P=NS). On day 28, the reduction in mean (SD) IOP in eyes treated with brimonidine tartrate 0.2% was significantly smaller (2.3 [1.8] mm Hg vs 3.9 [1.8] mm Hg [P=0.01]) and the mean (SD) percentage reduction in IOP was significantly smaller (13.4% [9.1%] vs 20.2% [7.5%] [P=0.01]) when compared with timolol maleate 0.5%, and likewise when compared with brinzolamide 1% (4.0 [2.1] mm Hg [P=0.02] and 22.7% [8.6%] [P=0.006], respectively). The group treated with brinzolamide was associated with a similar reduction in IOP to timolol (P=NS for both mean [SD] IOP and percentage reduction in IOP compared with timolol monotherapy). Barring the occasional conjunctival hyperemia, which was excluded as an adverse event for the purposes of this study, no adverse events were recorded. CONCLUSION: Brinzolamide 1% and timolol maleate 0.5% treatment were both associated with a significantly greater reduction in IOP compared with brimonidine 0.2% when administered as a nonfixed adjuvant to travoprost 0.004% in the treatment of patients with OAG and OHT whose IOP was inadequately controlled with travoprost monotherapy. All treatments were well tolerated.

Adrenergic alpha-Agonists↗
PubMed2000

Effects of latanoprost and timolol-XE on hydrodynamics in the normal eye.

PURPOSE: To compare the effects of latanoprost and timolol-XE on ocular pressure and perfusion in healthy adults, with respect to episcleral venous pressure. METHODS: A double-masked, placebo-controlled crossover study of weeklong bedtime treatment with one drop of drug, with placebo contralaterally, followed by a 3-week washout and alternate-drug/contralateral-placebo repeat. Intraocular pressure was measured by applanation and by pneumotonometry, providing pulsatile ocular circulatory estimates. Measurements of episcleral venous pressure were obtained (Friberg method). RESULTS: Twenty subjects participated (five men, 15 women; mean age, 39 years (range, 21 to 55 years); mean baseline intraocular pressure, 13.4 mm Hg). A greater decrease in intraocular pressure was seen among these subjects the morning after initiating treatment with latanoprost (-2.0 mm Hg; P <.0001) than with timolol-XE (-0.9 mm Hg; P =.051) (latanoprost versus timolol DeltaP =.008). This ocular hypotensive effect remained significant that evening with latanoprost (-3.2 mm Hg; P <.0001) but not with timolol XE (-1.0 mm Hg; P =.2). By the morning of day 8, mean intraocular pressure remained 3.2 mm Hg below baseline with latanoprost and 2.3 mm Hg below baseline with timolol-XE (P <.0001 for both drugs). Neither drug altered episcleral venous pressure. Among a subgroup of nine subjects with comparable intraocular pressure reductions with the two drugs, latanoprost treatment was associated with a 16.7% increase in mean pulsatile ocular blood flow (P =.04) through the weeklong treatment interval, consistently higher than during timolol-XE treatment of the same subjects. CONCLUSION: Latanoprost caused an overnight decrease in intraocular pressure in normotensive normal eyes, and both drugs significantly reduced intraocular pressure within 1 week. Intraocular pressure remained higher than episcleral venous pressure throughout treatment with both drugs. Latanoprost was associated with enhanced pulsatile ocular perfusion not seen with timolol-XE treatment.

Adrenergic beta-Antagonists↗
PubMed2001

Brimonidine 0.2% given two or three times daily versus timolol maleate 0.5% in primary open-angle glaucoma.

PURPOSE: To evaluate the efficacy and safety of brimonidine 0.2% two or three times daily versus timolol maleate 0.5% solution twice daily. METHODS: Patients with primary open-angle glaucoma were randomized by Latin square technique to one of the three treatment sequences in this crossover, prospective double-masked trial. Each treatment period consisted of 6 weeks of chronic dosing followed by a diurnal curve for the intraocular pressure measured at 08:00, 10:00, 16:00, 18:00, 20:00, 22:00, and 24:00 hours. Intraocular pressure was measured by applanation tonometry. RESULTS: Thirty patients completed this trial. The average diurnal intraocular pressures in the trial were measured for timolol maleate (17.7 +/- 2.7 mm Hg), brimonidine given three times daily (18.0 +/- 2.2 mm Hg), and brimonidine given twice daily (19.2 +/- 2.4 mm Hg). There was a statistical difference between groups (P <.005). When groups were compared by pairs, three times daily dosing with brimonidine and timolol maleate both reduced the pressure more than twice daily brimonidine at every time point past 10:00 hours and for the diurnal curve (P <.05). In contrast, three times daily brimonidine and timolol maleate were statistically similar for the diurnal pressure, and each time point, except timolol maleate, decreased the pressure more at 16:00 (P =.042). Safety was similar between groups. CONCLUSIONS: This study demonstrated that both timolol maleate twice daily and brimonidine three times daily provide a similar intraocular pressure reduction to each other. Timolol maleate twice daily and brimonidine three times daily provide a greater decrease in pressure in the late afternoon and nighttime hours, compared with brimonidine twice daily.

Adrenergic alpha-Agonists↗
PubMed2002

A double-masked randomized comparison of the efficacy and safety of unoprostone with timolol and betaxolol in patients with primary open-angle glaucoma including pseudoexfoliation glaucoma or ocular hypertension. 6 month data.

PURPOSE: A long-term comparison of the ocular hypotensive efficacy and safety of unoprostone isopropyl 0.15% twice daily with that of timolol maleate 0.5% twice daily and betaxolol HCl 0.5% twice daily. DESIGN: This was a randomized, multicenter, double-masked, active-controlled 24-month clinical trial involving 27 centers in Europe and Israel. METHODS: The study population was composed of patients with primary open-angle glaucoma (including pseudoexfoliation) or ocular hypertension. After washout of antiglaucoma medications, intraocular pressure (IOP) was measured at 0, + 2, + 8, and + 12 hours. Patients were randomized in a 2:1:1 ratio to unoprostone, timolol, or betaxolol. Patients returned for examinations at 2 and 6 weeks and 3 and 6 months. RESULTS: 556 patients were randomized. Each drug produced a clinically and statistically (P <.001) significant reduction from baseline in 12-hour diurnal IOP at month 6 (- 4.3 mm Hg, unoprostone; - 5.8 mm Hg, timolol; - 4.9 mm Hg, betaxolol). Differences in adjusted treatment means between unoprostone and timolol and unoprostone and betaxolol were 1.57 mm Hg (95% CI: 1.00, 2.13) and 0.53 mm Hg (95% CI: - 0.03, 1.09), respectively. Unoprostone was clinically equivalent to betaxolol but did not have as great an IOP-lowering effect as timolol. Discontinued for inadequate control of IOP were 7%, 1%, and 4% of the patients for unoprostone, timolol, and betaxolol, respectively. There were no changes of note in visual acuity, pupil size, cup-to-disk ratio, visual fields, or iris color. Changes in heart rate and blood pressure were small, with no clinically significant differences between groups. CONCLUSIONS: Unoprostone provided a clinically significant IOP-lowering effect equivalent to betaxolol but not to timolol. The side effect profile of unoprostone appears to be comparable to other established IOP-lowering agents.

Adrenergic beta-Antagonists↗