Test - Bimatoprost 0.01% Ophthalmic Solution for Glaucoma, Open-Angle

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Houston Eye Associates, North Loop, Houston, TX
Glaucoma, Open-Angle+3 More
Test - Bimatoprost 0.01% Ophthalmic Solution - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a randomized, double-blind, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. Test Product - Bimatoprost ophthalmic solution, 0.01% of Amneal EU, Limited Reference Product - LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.

Eligible Conditions

  • Glaucoma, Open-Angle
  • Glaucoma, Suspect

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.

Week 6
AE Monitoring for Safety of Bimatoprost ophthalmic solution 0.01%
Day 14
Mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

LUMIGAN® 0.01% Ophthalmic Solution
1 of 2
Bimatoprost 0.01% Ophthalmic Solution
1 of 2
Active Control
Experimental Treatment

168 Total Participants · 2 Treatment Groups

Primary Treatment: Test - Bimatoprost 0.01% Ophthalmic Solution · No Placebo Group · Phase 3

Bimatoprost 0.01% Ophthalmic Solution
Drug
Experimental Group · 1 Intervention: Test - Bimatoprost 0.01% Ophthalmic Solution · Intervention Types: Drug
LUMIGAN® 0.01% Ophthalmic Solution
Drug
ActiveComparator Group · 1 Intervention: Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.
Closest Location: Houston Eye Associates, North Loop · Houston, TX
Photo of Houston 1Photo of Houston 2Photo of Houston 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Glaucoma, Open-Angle
0 CompletedClinical Trials

Who is running the clinical trial?

CBCC Global ResearchNETWORK
3 Previous Clinical Trials
865 Total Patients Enrolled
1 Trials studying Glaucoma, Open-Angle
310 Patients Enrolled for Glaucoma, Open-Angle
Amneal Pharmaceuticals, LLCLead Sponsor
10 Previous Clinical Trials
27,597 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes.
Subjects must be willing and able to provide voluntary informed consent and to follow protocol requirements.
Subjects requiring treatment of both eyes and able to discontinue the use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
Subjects' IOP is likely to be controlled with monotherapy as per the Investigator's discretion.
You have a visual acuity of 20/100 or better in each eye, using a logarithmic visual acuity chart for testing at 10 feet (3 meters).
You are taking oral or parenteral (injection, patch, or implant) hormonal contraception which has been continuously used for at least 1 month prior to first dose of study medication.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.