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

PHASE1RecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

March 1, 2025

Study Completion Date

May 1, 2025

Conditions
Open-angle GlaucomaOcular Hypertension
Interventions
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.

Trial Locations (4)

30260

RECRUITING

Clayton Eye Research, Morrow

77008

RECRUITING

Houston Eye Associates, Houston

92663

RECRUITING

Eye Research Foundation, Newport Beach

93308

RECRUITING

West Coast Eye Institute, Bakersfield

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

CBCC Global Inc.

UNKNOWN

collaborator

Amneal EU, Limited

UNKNOWN

lead

Amneal Pharmaceuticals, LLC

INDUSTRY

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 | Biotech Hunter | Biotech Hunter