A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Public ClinicalTrials.gov record NCT07913074. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 2a, Randomized, Double-Masked, Double-Dummy, Parallel-Group Study to Evaluate the Intraocular Pressure (IOP)-Lowering Efficacy, Safety, and Tolerability of TB0001 (Pregabalin Ophthalmic Solution) Compared With Timolol 0.5% In Subjects With Primary Open-Angle Glaucoma (POAG) Or Ocular Hypertension (OHT)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07913074
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 96 participants
Conditions and interventions
Interventions
- Arm 1: TB0001 ophthalmic solution 0.9% Drug
- Arm 2: TB0001 ophthalmic solution 1.2% Drug
- TB0001 ophthalmic solution 1.5% Drug
- Timolol 0.05% eye drops Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 23, 2026 (Actual)
- Primary completion
- Jun 30, 2027 (Estimated)
- Completion
- Sep 30, 2027 (Estimated)
- Last update posted
- Nov 3, 2026
2026 – 2027
United States locations
- U.S. sites
- 3
- U.S. states
- 2
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Global Research Management, Inc | Glendale | California | 91204 | Recruiting |
| Eye Research Foundation, Inc | Newport Beach | California | 92663 | Recruiting |
| Piedmont Eye Center | Lynchburg | Virginia | 24502 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07913074, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 3, 2026 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07913074 live on ClinicalTrials.gov.