Trial comparing treatments for Primary Open - Angle Glaucoma (POAG)
Official title 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.
ClinicalTrials.gov ID: NCT07913074
What this study is testing
What is Arm 1: TB0001 ophthalmic solution 0.9%?
Arm 1: TB0001 ophthalmic solution 0.9% is an investigational medicine, being studied as a potential treatment for primary open - angle glaucoma (poag).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age more than or equal to 18 years.
- Diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
- Participants with POAG must have mild to moderate disease, defined as a visual field defect score of less than 12 on the Advanced Glaucoma...
- There must be documented evidence of a clinically meaningful reduction in IOP in response to currently used IOP-lowering medication(s), as determined...
- At the Baseline Visit Day -1 (after medication washout), IOP must be between 21 and 32 mmHg, measured at 8:30am ± 1 hour, and demonstrate more than...
You likely can't join if
- Ocular conditions that could confound study results, including but not limited to uveitis, macular disease, blepharitis, conjunctivitis, or any...
- History of herpes simplex keratitis.
- Severe dry eye disease or a clinical diagnosis of Sjögren's syndrome.
- Refractive error exceeding a spherical equivalent of more than 6 dioptres or axial length more than 26mm.
- Central corneal thickness less than 500 μm or more than 650 μm.
- Intraocular surgery within 3 months prior to Screening.
See the full eligibility criteria
- Age more than or equal to 18 years.
- Diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
- Participants with POAG must have mild to moderate disease, defined as a visual field defect score of less than 12 on the Advanced Glaucoma Intervention Study (AGIS) scale or a Humphrey Mean Deviation (MD)between 0 and...
- There must be documented evidence of a clinically meaningful reduction in IOP in response to currently used IOP-lowering medication(s), as determined by the investigator.
- At the Baseline Visit Day -1 (after medication washout), IOP must be between 21 and 32 mmHg, measured at 8:30am ± 1 hour, and demonstrate more than 20% or more than or equal to 3 mmHg increase in IOPcompared to the...
- No washout is required.
- At the Baseline Visit, IOP must be between 21 and 32 mmHg, measured at 8:30am ± 1 hour. Note: All screening IOP assessments must be conducted at 8:30am ± 1 hour to minimize variability due to diurnal fluctuation.
- Willing and able to discontinue existing IOP-lowering medication(s) and undergo a washout period of more than 14 days or more than 5 pharmacologic half-lives of the current agent(s), whichever is longer, as determined...
- Adequate ocular clarity and pupillary dilation to permit reliable ophthalmic assessments, including imaging procedures.
- Women of Non-Childbearing Potential (WONCBP), or
- Women of Childbearing Potential (WOCBP) with a negative serum pregnancy test at Screening and Baseline and agreement to use protocol-defined contraception throughout the study.
- Male people with partners of childbearing potential must agree to use protocol-defined contraception during the study.
- Willing and able to provide written informed consent and comply with study procedures, including in-clinic visits and at-home dosing requirements. note: only one eye will be included as a study eye.
- Ocular conditions that could confound study results, including but not limited to uveitis, macular disease, blepharitis, conjunctivitis, or any active ocular infection or inflammation.
- History of herpes simplex keratitis.
- Severe dry eye disease or a clinical diagnosis of Sjögren's syndrome.
- Refractive error exceeding a spherical equivalent of more than 6 dioptres or axial length more than 26mm.
- Central corneal thickness less than 500 μm or more than 650 μm.
- Intraocular surgery within 3 months prior to Screening.
- Ocular trauma within 6 months prior to Screening.
- Use of systemic calcium channel blockers that, in the opinion of the investigator, may interfere with study assessments or the mechanism of action of TB0001.
- Use of medical or recreational cannabis (marijuana) within 14 days prior to Screening (use during the study period is prohibited).
- Participation in another investigational drug or device study within 6 weeks prior to Screening.
- Any medical or psychiatric condition that, in the opinion of the investigator, may interfere with study participation, compliance, or interpretation of results.
- Advanced primary open-angle glaucoma (POAG), defined as a visual field defect score more than 12 month AGIS scale or a Humphrey Mean Deviation (MD) worse than -12 dB, including people with central visual field loss...
- Participants for whom washout of IOP-lowering therapy is deemed unsafe, including those with a history of uncontrolled IOP rebound during treatment withdrawal, documented progression of optic nerve damage associated...
- Known hypersensitivity or contraindication to pregabalin, timolol, beta-blockers, or any component of the study formulations.
- Clinically significant cardiovascular or respiratory conditions that would contraindicate the use of topical beta-blockers, including but not limited to bronchial asthma, severe chronic obstructive pulmonary disease...
The study team makes the final eligibility decision.
Where it is enrolling
- Glendale, California, United States
- Newport Beach, California, United States
- Lynchburg, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Glendale, California, United States; Newport Beach, California, United States; Lynchburg, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.