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
← catalyst calendarSponsored by Amneal Pharmaceuticals, LLC (industry) · AMRX — their whole pipeline →. With CBCC Global Inc., Amneal EU, Limited.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
240estimated
Sites
4
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-04-01 | actual | When the study began enrolling |
| Primary completion | 2025-03-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-01 | estimated | The whole study's end, after follow-up |
| First posted | 2024-02-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2024-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Open-angle Glaucoma
- Ocular Hypertension
Interventions
- Drug: Bimatoprost Ophthalmic Solution, 0.01%
- Drug: LUMIGAN® (bimatoprost ophthalmic solution) 0.01%
Primary outcome
what the primary-completion date above is the date OFPrimary Endpoint
measured 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
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