PURPOSE: To compare the efficacy and safety of diclofenac sodium 0.1% eyedrops packaged in an Abak multidose container without preservative (Dicloabak) with the reference product, sodium merthiolate-preserved diclofenac sodium 0.1% eyedrops, in controlling postoperative inflammation after cataract surgery. METHODS: The multicenter, controlled, randomized, single-masked study included 194 patients (Dicloabak 96, preserved diclofenac 98) scheduled to have cataract surgery by phacoemulsification with foldable intraocular lens. All were evaluated preoperatively and postoperatively after 1, 7, and 28 days. Postoperative inflammation was measured by the total score of anterior chamber cells and flare. Ocular plin, conjunctival hyperemia and ciliary flush were also assessed. Postoperative patient assessments also included visual acuity, objective tolerance by slit-lamp, fluorescein test, and subjective evaluation of local tolerance. RESULTS: There was no statistically significant difference between the groups in the total score of flare and cells or the degree of conjunctival hyperemia and ciliary flush at any study visit. Dicloabak was demonstrated to be not inferior to preserved diclofenac at all assessment times. The overall assessment of local tolerance was similar for both study medications. CONCLUSIONS: Preservative suppression did not alter diclofenac efficacy. Results support the good safety profile of both formulations when dosed three times daily for 4 weeks in absence of concomitant use of drugs potentially toxic for cornea. Preservative-free formulations like Dicloabak should be preferred to generic diclofenac formulations including other ingredients and may improve the safety profile of this topical nonsteroid anti-inflammatory drug.

Aged↗

PubMedDate not supplied

Ciprofloxacin ophthalmic solution versus rifamycin ophthalmic solution for the treatment of conjunctivitis and blepharitis.

The efficacy and safety of ciprofloxacin (0.3%) ophthalmic solution and rifamycin (1%) ophthalmic solution for the treatment of bacterial conjunctivitis and blepharitis was compared in this randomized, double-masked, parallel-group study. Forty-one patients, 19 on ciprofloxacin and 22 on rifamycin, were culture-positive on admission and evaluated for efficacy. There was clinical improvement in more than 90% of patients in each group at the end of the seven-day treatment period. However, clinical cure rates on day 7 appeared to be higher with ciprofloxacin (53%) than rifamycin (23%; p = 0.061, Mann-Whitney test). Bacteriological eradication rates were comparable: the infecting organisms were eradicated in 68% of patients on ciprofloxacin and 77% with rifamycin. There were no serious adverse reactions to either treatment. One patient in each group was withdrawn on account of a mild allergy. In conclusion, topical ciprofloxacin was effective and well tolerated and would be a particularly useful agent for the treatment of bacterial conjunctivitis and blepharitis.

Acute Disease↗

PubMedDate not supplied

Comparative evaluation of efficacy and safety of ciprofloxacin and norfloxacin ophthalmic solutions.

The efficacy and safety of ciprofloxacin ophthalmic solution 0.3% and norfloxacin ophthalmic solution 0.3% in the treatment of bacterial conjunctivitis and blepharitis were compared in a double masked randomised study. A total of 131 patients, 65 treated with ciprofloxacin (42 with conjunctivitis and 23 with blepharitis) and 66 treated with norfloxacin (39 with conjunctivitis and 27 with blepharitis) were enrolled in the study at five centres in France. In the efficacy population, pathogens were eradicated or reduced in 96% (24/25) of patients in the ciprofloxacin group and 89% (24/27) in the norfloxacin group. There was no difference between treatments with regard to eradication of particular pathogens. In the efficacy population, clinical cure or improvement was seen in 96% of the patients (24/25 in the ciprofloxacin group and 26/27 in the norfloxacin group). There were no significant differences between ciprofloxacin and norfloxacin with respect to improvements in four symptoms or ten clinical signs. No serious treatment-related adverse events were reported and both ciprofloxacin and norfloxacin were well tolerated.

Anti-Infective Agents↗

PubMedDate not supplied

Ciprofloxacin ophthalmic solution in the treatment of conjunctivitis and blepharitis: a comparison with fusidic acid.

The efficacy and safety of ciprofloxacin ophthalmic solution (0.3%) and fusidic acid gel (1%) were compared in the treatment of bacterial conjunctivitis and blepharitis in a randomized, open, parallel group study. Thirty-nine patients, 21 treated with ciprofloxacin solution and 18 treated with fusidic acid gel, were culture-positive on admission and were evaluable for efficacy. At the end of a 7-day treatment, the infecting organism was eradicated in 81% of those treated with ciprofloxacin and 72% of those treated with fusidic acid gel. There was clinical cure or improvement in 95% and 89% respectively. The clinical cure rate appeared to be higher with ciprofloxacin than fusidic acid (62% compared with 28%) but this was related to the higher proportion of patients with acute conjunctivitis in the ciprofloxacin group. Two patients using ciprofloxacin had mild discomfort and stinging on instillation and one given fusidic acid had moderate edema and discomfort; the latter patient stopped treatment. Topical ciprofloxacin is effective and well tolerated and is a useful treatment of bacterial conjunctivitis and blepharitis.

Adolescent↗