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.

Korábbi kezelés

• Intraocular surgery within 3 months prior to Screening.
• Ocular trauma within 6 months prior to Screening.
• Participation in another investigational drug or device study within 6 weeks prior to Screening.
• 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 with prior washout attempts, or any other condition where IOP elevation during washout would pose undue risk, in the opinion of the investigator.

Más betegség

• 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.
• Any medical or psychiatric condition that, in the opinion of the investigator, may interfere with study participation, compliance, or interpretation of results.
• 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, sinus bradycardia, or second- or third-degree atrioventricular block not controlled with a pacemaker.

Laborértékek

• 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).

Egyéb

• 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.
• 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 subjects with central visual field loss threatening fixation.

• 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 -12 dB.
• Intraocular Pressure (IOP) Criteria (study eye):
  • For participants currently receiving IOP-lowering therapy:
  • 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 pre-washout measurement.
  • For participants not currently receiving IOP-lowering therapy (i.e., untreated POAG or untreated OHT):
  • 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 by the investigator.
• Adequate ocular clarity and pupillary dilation to permit reliable ophthalmic assessments, including imaging procedures.
• Female subjects:
  • 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 subjects 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.