Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% to LUMIGAN® In The Treatment of Chronic Open-Angle Glaucoma

PHASE3CompletedINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

October 2, 2021

Primary Completion Date

August 11, 2022

Study Completion Date

August 11, 2022

Conditions
Glaucoma, Open-Angle
Interventions
DRUG

Test - Bimatoprost 0.01% Ophthalmic Solution

Subjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days.

DRUG

Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)

Subjects in the second arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days.

Trial Locations (9)

33029

CBCC Global Research Site 020, Pembroke Pines

77008

CBCC Global Research Site 018, Houston

91107

CBCC Global Research Site 013, Pasadena

91345

CBCC Global Research Site 016, Mission Hills

92122

CBCC Global Research Site 015, San Diego

92663

CBCC Global Research Site 017, Newport Beach

CBCC Global Research Site: 012, Newport Beach

93308

CBCC Global Research Site:011, Bakersfield

94954

CBCC Global Research Site 019, Petaluma

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

CBCC Global Research

NETWORK

lead

Mankind Pharma Limited

INDUSTRY