Twelve-month, randomized, controlled trial of bimatoprost 0.01%, 0.0125%, and 0.03% in patients with glaucoma or ocular hypertension
| Autor: | Amy L. Batoosingh, Vincent Shu, L. Jay Katz, John S. Cohen, Rhett M. Schiffman, Carlos Felix |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Male Intraocular pressure medicine.medical_specialty Eye disease Glaucoma Ocular hypertension law.invention Tonometry Ocular Young Adult Randomized controlled trial Double-Blind Method law Ophthalmology Surveys and Questionnaires Medicine Humans Prospective Studies Prospective cohort study Antihypertensive Agents Intraocular Pressure Aged Aged 80 and over Bimatoprost business.industry Cloprostenol Middle Aged medicine.disease Amides Tolerability Patient Satisfaction Female Ocular Hypertension business medicine.drug |
| Zdroj: | American journal of ophthalmology. 149(4) |
| ISSN: | 1879-1891 |
| Popis: | Purpose To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of ophthalmic formulations of bimatoprost 0.01% and 0.0125% compared with bimatoprost 0.03%. Design Prospective, randomized, double-masked, multicenter clinical trial. Methods Patients with glaucoma or ocular hypertension were randomized to receive once-daily bimatoprost 0.01% (n = 186), bimatoprost 0.0125% (n = 188), or bimatoprost 0.03% (n = 187) for 12 months. The primary efficacy measure was IOP. Safety measures included adverse events and an objective assessment of conjunctival hyperemia. Results Baseline mean IOPs were similar among treatment groups. Differences in mean IOP between the bimatoprost 0.01% or 0.0125% groups and the bimatoprost 0.03% group were less than 0.9 mm Hg throughout follow-up. Bimatoprost 0.01%, but not bimatoprost 0.0125%, was equivalent in efficacy to bimatoprost 0.03% based on predetermined criteria (limits of the 95% confidence interval of the between-group difference in mean IOP within ± 1.5 mm Hg at all time points and within ± 1 mm Hg at most time points). The overall incidence of treatment-related adverse events was reduced significantly in the bimatoprost 0.01% and bimatoprost 0.0125% groups compared with the bimatoprost 0.03% group ( P ≤ .034). The percentage of patients with a moderate to severe increase from the baseline macroscopic hyperemia score was: bimatoprost 0.01%, 3.2%; bimatoprost 0.0125%, 9.0%; bimatoprost 0.03%, 9.1% ( P = .019 for bimatoprost 0.01% vs 0.03%). Conclusions Bimatoprost 0.01% was equivalent to bimatoprost 0.03% in lowering IOP throughout 12 months of treatment and demonstrated improved tolerability, including less frequent and severe conjunctival hyperemia. Bimatoprost 0.01% demonstrated a better benefit-to-risk ratio than bimatoprost 0.0125%. |
| Databáze: | OpenAIRE |
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