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A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

Ocular Hypertension Clinical Trial

Official title:
A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint Comparing Generic Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® (Bimatoprost Ophthalmic Solution) 0.01% in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

Clinical Trial Summary

A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study

Clinical Trial Description

Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes who meet all of the inclusion criteria and none of the exclusion criteria will be identified. Potential subjects will be screened within 6 weeks prior to administration of the first drop of study drug. They will undergo a washout period of 4 days to 4 weeks (28 days) based on their current medication (if available). Based on stratification criteria, IOP and CCT information available at baseline visit for each subject, the subjects will be randomized in such way that ratio of treatment distribution will be nearer to 1:1 between the treatment arms, and within the combined stratification criteria. The Primary Endpoint is mean difference in the IOP of both eyes between the two treatment groups at 3 time points, i.e., at 00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at Day 14 (Week 2) (± 4 days) and Day 42 (Week 6) (± 4 days) visits. The Secondary Endpoint: the incidence of all adverse events reported during the study will be summarized by treatment group. Test and reference products will be compared for safety by analyzing nature, severity and frequency of treatment emergent adverse events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06267274
Study type Interventional
Source Amneal Pharmaceuticals, LLC
Contact Ilesh Changela, MD
Phone +91-79-67778300
Email ilesh@amneal.com
Status Not yet recruiting
Phase Phase 1
Start date April 1, 2024
Completion date May 1, 2025
View Details
See also
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