Artikel
A randomized, double masked, active controlled, crossover phase III equivalence study of generic dorzolamide 2% versus innovator Trusopt® eye drop solution in subjects with open angle glaucoma or ocular hypertension
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Veröffentlicht: | 13. Juni 2023 |
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Gliederung
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Background: The aim of this study was to demonstrate the equivalence of generic dorzolamide 2% eye drops solution versus the innovator formulation (Trusopt® eye drops solution) in patients with open angle glaucoma or ocular hypertension.
Methods: This prospective, monocentric, double masked, active controlled crossover phase III study included 32 patients. After washout, patients were randomized to Reference product (Trusopt®) or Test product (Dorzolamide 2% eye drops, Rompharm Company SRL) for a 4-week period. Subsequent washout and crossover was performed. Drops were applied t.i.d. Primary efficacy endpoint was the difference in mean diurnal IOP. Goldmann applanation tonometry was performed at 8 am, 12 pm, and 4 pm at each visit, safety was assessed by documentation of adverse events (AEs). Therapy adherence was documented by self-reporting and eye drop bottle weighing. An ANOVA with treatment, sequence, study period, and patient within sequence as effects was performed and an additional post-hoc ANCOVA including the baseline IOP.
Results: 34 patients were randomized and analyzed in the safety population. The per protocol population included 32 patients. According to self-report, all patients were >80% compliant. Under the ANCOVA model, the 90% confidence interval for the average change of the IOP -0.27 mmHg [-1.17 mmHg – 0.64 mmHg] is included by the acceptance range -1.5 mmHg to +1.5 mmHg after excluding 2 patients, that had falsely reported high therapy adherence. No clinically relevant difference was observed in frequency or severity of the AEs between both treatments.
Conclusion: This study showed the equivalence of the tested generic dorzolamide 2% eye drops solution to the reference product Trusopt® eye drops solution.