NCT05401357View on ClinicalTrials.gov

Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.

PHASE3RecruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

June 29, 2022

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2022

Conditions
Glaucoma, Open-AngleOcular Hypertension
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 ± 1 hour for 42 days.

DRUG

Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)

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

Trial Locations (9)

30076

RECRUITING

Coastal Research Associates, LLC, Roswell

30260

RECRUITING

Clayton Eye Clinical Research, LLC, Morrow

32169

RECRUITING

Volusia Eye Associates, New Smyrna Beach

37215

RECRUITING

Toyos Clinic, Nashville

77008

RECRUITING

Houston Eye Associates, North Loop, Houston

78731

NOT_YET_RECRUITING

Keystone Research, Austin

82001

RECRUITING

Cheyenne Eye Clinic & Surgery Center, Cheyenne

92663

RECRUITING

Eye Research Foundation Inc., Newport Beach

94954

RECRUITING

North Bay Eye Associates, Inc., Petaluma

Sponsors

Collaborators (1)

CBCC Global Research
All Listed Sponsors
collaborator

CBCC Global Research

NETWORK

lead

Amneal Pharmaceuticals, LLC

INDUSTRY

NCT05401357 - Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes. | Biotech Hunter | Biotech Hunter