NCT06267274

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Amneal Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Open-angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Bimatoprost Ophthalmic Solution, 0.01%	1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule.
DRUG	LUMIGAN® (bimatoprost ophthalmic solution) 0.01%	1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-03-01
• Completion: 2025-05-01
• First posted: 2024-02-20
• Last updated: 2024-08-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study