← Back to Search

Prostaglandin Analog

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

Phase 3
Recruiting
Research Sponsored by Amneal Pharmaceuticals, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.
Awards & highlights

Study Summary

This trial is designed to show that a generic bimatoprost solution is equivalent to the brand name product in subjects with glaucoma or ocular hypertension.

Eligible Conditions
  • Open-Angle Glaucoma
  • Ocular Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours.
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 and 42 at 00.00 hours, 04.00 hours, and 08.00 hours. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups.
Secondary outcome measures
AE Monitoring for Safety of Bimatoprost ophthalmic solution 0.01%

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bimatoprost 0.01% Ophthalmic SolutionExperimental Treatment1 Intervention
Pharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.
Group II: LUMIGAN® 0.01% Ophthalmic SolutionActive Control1 Intervention
Pharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bimatoprost
FDA approved

Find a Location

Who is running the clinical trial?

Amneal Pharmaceuticals, LLCLead Sponsor
11 Previous Clinical Trials
27,837 Total Patients Enrolled
CBCC Global ResearchNETWORK
7 Previous Clinical Trials
1,115 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining places in this clinical trial that a patient could fill?

"The trial, which was last updated on 8/9/2022, is currently seeking patients, as per the information on clinicaltrials.gov"

Answered by AI

Has the Test - Bimatoprost 0.01% Ophthalmic Solution been federally authorized for use?

"We believe that Test - Bimatoprost 0.01% Ophthalmic Solution is safe, which is reflected in its Phase 3 status. This indicates that not only is there some data supporting efficacy, but also that there have been multiple rounds of data supporting safety."

Answered by AI

How many individuals are involved with this research project?

"That is correct, the clinical trial is recruiting. The original posting was on June 29th, 2022 and the last update was on August 9th, 2022. The trial is looking for 168 participants that are willing to go to one of the 9 locations."

Answered by AI

In how many places is this trial being conducted?

"There are 9 running for this study including Volusia Eye Associates in New Smyrna Beach, North Bay Eye Associates, Inc. in Petaluma, and Eye Research Foundation Inc. in Newport Beach."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Houston Eye Associates, North Loop
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
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.
2022. "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.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05401357.
All > Glaucoma > Latisse
~61 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top