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Prostaglandin Analog

Unpreserved Bimatoprost for Glaucoma

Phase 3
Waitlist Available
Research Sponsored by Laboratoires Thea
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Both eyes diagnosed open-angle glaucoma or ocular hypertension
Both eyes diagnosed open-angle glaucoma or ocular hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week12
Awards & highlights

Study Summary

This trial is testing whether a new glaucoma medication is as effective as the current standard medication.

Who is the study for?
This trial is for individuals with open-angle glaucoma or ocular hypertension in both eyes who have signed an informed consent. It's not suitable for those with recent eye trauma, infection, significant inflammation, known allergies to the medication components, or if they are pregnant or breastfeeding.Check my eligibility
What is being tested?
The study aims to show that T4032 (a preservative-free version of Bimatoprost 0.01%) is just as effective as Lumigan® 0.01% in treating patients with ocular hypertension or glaucoma.See study design
What are the potential side effects?
Potential side effects may include redness of the eyes, growth of eyelashes, itchy eyes, dryness or discomfort around the eye area; however specific side effects for T4032 will be monitored and compared to Lumigan®.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Both of my eyes have been diagnosed with open-angle glaucoma or high eye pressure.
Select...
Both of my eyes have been diagnosed with open-angle glaucoma or high eye pressure.
Select...
Both of my eyes have been diagnosed with open-angle glaucoma or high eye pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week12
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: T4032Experimental Treatment1 Intervention
Group II: LumiganActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bimatoprost Ophthalmic
2023
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Laboratoires TheaLead Sponsor
54 Previous Clinical Trials
5,886 Total Patients Enrolled
6 Trials studying Ocular Hypertension
1,808 Patients Enrolled for Ocular Hypertension

Frequently Asked Questions

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

How many people are joining this clinical trial?

"The clinical trial is presently looking for patients to enroll, with 500 individuals needed between 2 sites. The study was initially posted on 6/22/2022 and was last updated on 7/18/2022."

Answered by AI

Are there any unfilled openings for patients who wish to enroll in this research study?

"The study, which can be found clinicaltrials.gov, is currently looking for participants. This particular trial was originally posted on June 22nd, 2020 and was last edited on July 18th, 2020."

Answered by AI

Has Bimatoprost Ophthalmic been cleared by the FDA?

"Bimatoprost Ophthalmic, which is currently in Phase 3 clinical trials, has demonstrated efficacy in prior studies and multiple rounds of data support its safety--giving it a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
California
Pennsylvania
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
What site did they apply to?
Scheie Eye Institute

Why did patients apply to this trial?

I am 73 years old female I have catarac in my eyes I have been operete once on the eye but I can't even from distance.
PatientReceived 2+ prior treatments
~249 spots leftby Mar 2025