Pregabalin Eye Drops for Glaucoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is evaluating a new eye drop containing pregabalin (TB0001) as a potential treatment for people with primary open-angle glaucoma or ocular hypertension. The study aims to determine whether TB0001 lowers eye pressure as effectively as timolol, a commonly used glaucoma eye drop, while remaining safe and well tolerated. Participants will be randomly assigned to receive one of three strengths of TB0001 or timolol for 28 days. Eye pressure, eye health, side effects and tolerability will be assessed throughout the study. The results will help identify the most appropriate dose of TB0001 for future clinical studies.
Who Is on the Research Team?
Lukas Scheibler, PhD
Principal Investigator
Tavo Biotherapeutics, Inc
Are You a Good Fit for This Trial?
This trial is for adults with open-angle glaucoma or high eye pressure, including pigmentary glaucoma and those at risk after eye surgery. Participants should not have other serious eye conditions or health issues that could interfere with the study.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- TB0001 ophthalmic solution
- Timolol
Trial Overview
The study compares three different strengths of a new pregabalin-based eye drop (TB0001) to timolol, a standard glaucoma treatment. Participants are randomly assigned to one group and use the drops daily for 28 days to see which lowers eye pressure best.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Pregabalin ophthalmic solution (TB0001) 1.5% administered as one drop in the study eye once daily in the morning for 28 days. Participants also administer a matching vehicle ophthalmic solution as one drop into the study eye once daily in the evening as part of the double-dummy design to maintain masking.
Pregabalin ophthalmic solution (TB0001) 1.2% administered as one drop in the study eye once daily in the morning for 28 days. Participants also administer a matching vehicle ophthalmic solution as one drop into the study eye once daily in the evening as part of the double-dummy design to maintain masking.
Pregabalin ophthalmic solution (TB0001) 0.9% administered as one drop in the study eye once daily in the morning for 28 days. Participants also administer a matching vehicle ophthalmic solution as one drop into the study eye once daily in the evening as part of the double-dummy design to maintain masking.
The comparator product is timolol maleate ophthalmic solution 0.5%. It will be administered twice daily (AM + PM)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tavo Biotherapeutics
Lead Sponsor
True North Therapeutics
Industry Sponsor
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