Pregabalin (PRG) ophthalmic solutions in patients diagnosed with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Phase 1, randomized, single-masked, multiple ascending dose (MAD) study designed to evaluate the safety, tolerability, and preliminary efficacy of pregabalin (PRG) ophthalmic solutions in patients diagnosed with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Tavo Biotherapeutics
32 participants
Sep 9, 2025
Interventional
Conditions
Summary
This study is a Phase 1, randomized, single-masked, multiple ascending dose (MAD) study designed to evaluate the safety, tolerability, and preliminary efficacy of pregabalin (PRG) ophthalmic solution in patients diagnosed with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The study will be conducted at up to 3 clinical sites and will include up to 32 participants, divided into 4 escalating dose cohorts. The study will employ a single-masked design, meaning that the evaluating investigator and subjects will remain unaware of the treatment allocation, while other study personnel, including the sponsor, Safety Review Committee (SRC), and medical monitor, will be unmasked. The comparator arm will use XALATAN (latanoprost ophthalmic solution), a well-established drug used for lowering intraocular pressure (IOP). This study aims to determine the safety profile of pregabalin eye drops and to explore its effects on IOP and corneal sensitivity over a three-day treatment period.
Eligibility
Inclusion Criteria14
- Age more than or equal to 40 years.
- Diagnosed with mild to moderate POAG or OHT, treated with less than or equal to 2 IOP-lowering medications.
- o Participants with POAG must have a visual field defect score of less than 12 on the AGIS scale
- IOP Criteria (of study eye):
- o At screening (before washout): less than 24 mmHg.
- o At baseline (after washout): 22-34 mmHg.
- Note: Participants who are not currently using IOP-lowering therapy (i.e., untreated OHT or POAG) are exempt from washout and may proceed directly to Baseline if all other criteria are met.
- Willing and able to discontinue existing IOP-lowering medication(s) and undergo a washout period of 14 to 28 days, or more than or equal to 5 pharmacologic half-lives of the current agent(s), as determined by the investigator.
- Adequate ocular clarity and pupillary dilation for imaging.
- Female subjects:
- o Women of Non-Childbearing Potential (WONCBP) or
- o Women of Childbearing Potential (WOCBP) with a negative serum pregnancy test and use of protocol-defined contraception.
- Males with female partners must agree to protocol-defined contraception.
- Willing and able to provide informed consent
Exclusion Criteria15
- Ocular conditions that could confound results:
- o Uveitis, macular diseases, blepharitis, conjunctivitis.
- o History of herpes simplex keratitis.
- o Spherical equivalent more than 6 diopters or axial length more than 26mm (for clarity: measuring only one parameter as part of determining eligibility is acceptable)
- Central corneal thickness less than 500 micrometres or more than 650 micrometres.
- Recent intraocular surgery (within 3 months).
- Ocular trauma (within 6 months).
- Use of systemic calcium channel blockers.
- Participation in another investigational drug trial within 6 weeks.
- Medical or psychiatric conditions may affect compliance.
- Advanced Primary Open-Angle Glaucoma (POAG), defined as a visual field defect score more than or equal to 12 on the Advanced Glaucoma Intervention Study (AGIS) scale. This includes participants with central visual field loss threatening fixation, due to the increased risk of functional deterioration during washout and investigational treatment.
- o Participants for whom washout of IOP-lowering therapy is deemed unsafe, including those with:
- History of uncontrolled IOP rebound during treatment withdrawal
- Optic nerve cupping progression related to prior washout attempts
- Any other condition where IOP elevation during washout would pose undue risk, in the opinion of the investigator
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Interventions
This study is a Phase 1, randomized, single-masked, multiple ascending dose (MAD) study designed to evaluate the safety, tolerability, and preliminary efficacy of pregabalin (PRG) ophthalmic solution (TB0001-EAP05) in patients diagnosed with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT). This study aims to determine the safety profile of pregabalin eye drops and to explore its effects on Intraocular Pressure (IOP) and corneal sensitivity over a three-day treatment period. The study will be conducted at up to 3 clinical sites and will include up to 32 participants, divided into 4 escalating dose cohorts (8 participants per cohort, 6 receiving TB0001-EAP05): • Cohort 1: 3 mg/mL • Cohort 2: 6 mg/mL (provisional) • Cohort 3: 12 mg/mL (provisional) • Cohort 4: 20mg/mL (provisional) The doses for Cohorts 2-4 are provisional and will be adjusted based on safety, tolerability, and emerging IOP-lowering data.. The study is divided into four phases: Screening Phase occurs at least 14 days but not more than 60 days prior to Baseline Visit (Visit 2) to confirm eligibility and baseline ocular and systemic health. Washout Period for participants currently receiving topical IOP-lowering medications at screening will be required to undergo a washout period of 14 to 28 days, or a duration equivalent to at least five pharmacologic half-lives of their existing IOP-lowering agent(s), whichever is longer. This is to ensure complete clearance of drug effect prior to baseline IOP assessment and investigational product dosing. Participants who are not on any IOP-lowering therapy at screening (e.g., untreated OHT or POAG) are exempt from this requirement. Baseline and Treatment Phase: where participants will be randomized within each cohort in a 6:2 ratio. 6 participants in all dose cohort will receive TB0001-EAP05 topically as a 35 µL dose on site once daily for three consecutive days, followed by post-treatment assessments to evaluate safety and pharmacodynamic effects. The volume of intervention remains the same for each dose cohort, with the concentration being adjusted. Post-Treatment Phase where a comprehensive safety and efficacy evaluation will be conducted on 4 days post first dose at the clinical site. Each participant will participate in the trial for up to 64 days. Adherence to the intervention is monitored by study staff as the intervention is only given on site.
Locations(1)
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ACTRN12625000766415