Pregabalin (PRG) ophthalmic solutions in patients diagnosed with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

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.