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R A Laibovitz

Publications and source records attributed to R A Laibovitz.

17 recordsLinked to original sources

Comparison of the ocular hypotensive lipid AGN 192024 with timolol: dosing, efficacy, and safety evaluation of a novel compound for glaucoma management.

OBJECTIVE: To compare the safety and efficacy of the ocular hypotensive lipid AGN 192024 (Lumigan) with those of timolol. METHODS: A 30-day, randomized, investigator-masked, clinical trial involving 100 patients with elevated intraocular pressure (IOP). Study medications were instilled topically. Doses of 0.003%, 0.01%, or 0.03% AGN 192024 were given once daily for 3 weeks then twice daily for 1 week, and vehicle control or 0.5% timolol was given twice daily for 4 weeks. Mean change in IOP from baseline was the primary efficacy variable. Safety parameters included adverse events, hyperemia grading, laser flare meter analysis, heart rate, and blood pressure. RESULTS: Timolol and all 3 concentrations of AGN 192024 lowered IOP from baseline (P < .001). A dosage of 0.03% AGN 192024 once daily lowered IOP significantly more than timolol (P < or = .02) at every study visit except day 21 (P = .053) and provided better diurnal IOP control. Twice-daily dosing of AGN 192024 provided no clinically significant benefit over once-daily dosing. All treatment regimens were safe and well tolerated, with no clinically significant effects on heart rate or blood pressure and no between-group differences in the incidence of adverse events. The only significant ocular safety finding with AGN 192024 was a dose-related mild increase in conjunctival hyperemia. CONCLUSIONS: Of the 3 concentrations tested, 0.03% AGN 192024 once daily had the best therapeutic profile. AGN 192024 was safe and well tolerated, and it provided superior ocular hypotensive efficacy and diurnal IOP control compared with timolol in patients with ocular hypertension and glaucoma.

Adult↗

Effects of carteolol and timolol on plasma lipid profiles in older women with ocular hypertension or primary open-angle glaucoma.

PURPOSE: To determine the effect on serum lipid levels of carteolol hydrochloride 1.0% or timolol maleate 0.5% given twice a day to women age 60 years and older with primary open-angle glaucoma or ocular hypertension. METHOD: We included 112 patients in this double-masked, randomized, multicenter trial. Fasting clinical laboratory studies were evaluated at baseline and at 12 weeks. Patients were instructed not to change their dietary, alcohol consumption, or exercise habits during the study. RESULTS: For the carteolol group, the high-density lipoprotein (HDL) and total cholesterol/high-density lipoprotein (TC/HDL) ratio at baseline of 50.1 +/- 1.5 mg/dl and 4.7 +/- 0.2 changed by the 12-week visit to 51.3 +/- 1.9 mg/dl (P = .25) and 4.6 +/- .02 (P = .47), respectively. For the timolol maleate group, the baseline HDL and TC/HDL ratio of 53.6 +/- 2.2 mg/dl and 4.4 +/- 0.2 changed to 50.2 +/- 1.9 mg/dl (P < .001) and 4.7 +/- 0.2 (P = .001), respectively, at the 12-week visit. Carteolol patients showed no significant change from baseline, whereas the HDL (P < .001) and TC/HDL ratio decreased (P = .001) significantly in the timolol maleate group. There also was a significant difference in the change from baseline at 12 weeks between carteolol and timolol maleate groups for the HDL and TC/HDL ratio (P = .01 and .012, respectively). No differences in TC, low-density lipoprotein (LDL), or triglycerides (TG) or in changes from baseline were observed between groups at 12 weeks (P > .05). At 12 weeks, no differences were observed between carteolol and timolol maleate groups in intraocular pressure or safety (P > .05), except that patients given carteolol demonstrated fewer solicited ocular symptoms (P = .007). CONCLUSIONS: Carteolol appears to be neutral in its effect on serum lipid levels, whereas timolol maleate adversely affects the HDL and TC/HDL ratio in women age 60 years and older with ocular hypertension or primary open-angle glaucoma.

Adrenergic beta-Antagonists↗

A multicenter comparison of the ocular efficacy and safety of diclofenac 0.1% solution with that of ketorolac 0.5% solution in patients with acute seasonal allergic conjunctivitis.

Only one of several available ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) is currently FDA approved for use in acute seasonal allergic conjunctivitis (SAC). Sixty patients with SAC and moderate itching and bulbar conjunctival injection were enrolled in a multicenter, randomized, double-masked, parallel-group trial comparing diclofenac sodium (DS) with ketorolac tromethamine (KT). Patients instilled 1 drop four times daily while awake for 14 days. Ocular signs and symptoms were evaluated at one and two weeks. The primary efficacy variables were itching and bulbar conjunctival injection. For both treatments, the ocular allergy sign and symptom scores were comparable at baseline. Both treatments evaluated in this study were well tolerated. Significant clinical and statistical reductions from baseline were observed in the primary efficacy variables. Treatment group differences were observed for the pain/soreness score with an advantage observed for the DS group at 30 minutes and at day 7. Our conclusion is that diclofenac sodium and ketorolac tromethamine acted similarly to reduce the ocular signs and symptoms associated with acute seasonal allergic conjunctivitis. There was a statistically significant advantage for the DS group to be free of symptoms at the day 7 visit as compared to the KT group (20.7% vs. 3.2%).

Acute Disease↗

Safety and efficacy of diclofenac sodium 0.1% ophthalmic solution in acute seasonal allergic conjunctivitis.

A randomized clinical trial was conducted to compare diclofenac sodium 0.1% ophthalmic solution to placebo in relieving ocular signs and symptoms in patients with acute seasonal allergic conjunctivitis. Twenty patients (10 per treatment) qualified for this two week, double-masked study with moderate itching, bulbar conjunctival injection and a positive skin test. Diclofenac was statistically and clinically superior in the physician's global evaluation (p = 0.03) and the primary composite score [itching + bulbar/palpebral conjunctival injection (p = 0.037)] after two weeks of treatment. Four patients experienced some transient ocular burning/stinging with diclofenac. Diclofenac sodium appears to be effective for relieving the ocular signs and symptoms associated with acute seasonal allergic conjunctivitis.

Acute Disease↗

Pilot trial of cyclosporine 1% ophthalmic ointment in the treatment of keratoconjunctivitis sicca.

This trial was a randomized, double-masked, crossover study during which patients with keratoconjunctivitis sicca underwent 6 weeks of treatment with either cyclosporine 1% ophthalmic ointment or placebo followed by 6 weeks of the alternative treatment. Washout periods using only unpreserved artificial tears preceded both treatment cycles. Twenty-five patients completed the first treatment period, but only eight met entry criteria for period II. Cyclosporine ointment was associated with initial mild to moderate redness, itching, and burning that returned to baseline levels within 1-2 weeks. Rose Bengal results and results of four subjective (patient diary) efficacy parameters favored cyclosporine: foreign body sensation, overall symptoms, hours of symptom control per day, and overall effectiveness. No systemic adverse events or laboratory abnormalities occurred. We conclude that (a) the crossover design is inappropriate for studying this disease; (b) mild to moderate itching, redness, and burning occur initially with cyclosporine administration, although tolerance quickly develops; (c) cyclosporine appears to benefit the ocular surface in keratoconjunctivitis sicca; and (d) further trials in this syndrome are warranted.

Adult↗

Presumed phlebitis of the optic disc.

The clinical picture of unilateral disc edema suggests the presence of ocular, orbital, or intracranial disease. This report focuses on a poorly appreciated and often overlooked cause of unilateral disc edema, presumed phlebitis of the optic disc, along with a review of the literature. Typical case presentations are reviewed, and emphasis is placed on the neurophthalmologic approach to this entity. An appropriate diagnostic evaluation and indications for treatment are presented. Awareness of this syndrome can eliminate extensive neurodiagnostic procedures for the patient with a typical clinical picture.

Adult↗