None listed
Conditions
Brief summary
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.
Interventions
Intervention 1:
Pregabalin ophthalmic solution (TB0001) 0.9% administered as one drop into the study eye(s) once daily in the morning for 28 days. Participants also administer a matching vehicle ophthalmic solution as one drop into the study eye(s) once daily in the evening as part of the double-dummy design to maintain masking. The study treatment is supplied in sterile, preservative-free, single-use ophthalmic containers for topical ocular administration. Morning doses on clinic visit days (Da
Intervention 1: Pregabalin ophthalmic solution (TB0001) 0.9% administered as one drop into the study eye(s) once daily in the morning for 28 days. Participants also administer a matching vehicle ophthalmic solution as one drop into the study eye(s) once daily in the evening as part of the double-dummy design to maintain masking. The study treatment is supplied in sterile, preservative-free, single-use ophthalmic containers for topical ocular administration. Morning doses on clinic visit days (Days 1, 3, 7, 14 and 28) are administered under supervision, while all remaining doses are self-administered at home. Adherence is assessed through participant dosing records and study drug accountability, with missed or incorrect doses documented. Intervention 2: Pregabalin ophthalmic solution (TB0001) 1.2% administered as one drop into the study eye(s) once daily in the morning for 28 days. Participants also administer a matching vehicle ophthalmic solution as one drop into the study eye(s) once daily in the evening as part of the double-dummy design to maintain masking. The study treatment is supplied in sterile, preservative-free, single-use ophthalmic containers for topical ocular administration. Morning doses on clinic visit days are supervised, with all other doses administered at home. Adherence is assessed through participant dosing records and study drug accountability. Intervention 3: Pregabalin ophthalmic solution (TB0001) 1.5% administered as one drop into the study eye(s) once daily in the morning for 28 days. Participants also administer a matching vehicle ophthalmic solution as one drop into the study eye(s) once daily in the evening as part of the double-dummy design to maintain masking. The study treatment is supplied in sterile, preservative-free, single-use ophthalmic containers for topical ocular administration. Morning doses on clinic visit days are supervised, with all other doses administered at home. Adherence is assessed through participant dosing records and study drug accountability. Washout of prior IOP-lowering therapy: Participants receiving IOP-lowering therapy at screening must discontinue this treatment during the screening period and complete the protocol-required washout before the Baseline Visit on Day -1 and commencement of study treatment on Day 1. The minimum washout is approximately 2 weeks for participants previously treated with timolol and approximately 4 weeks for all other IOP-lowering treatments, including combination therapies. In every case, the washout must exceed 14 days or five pharmacological half-lives of the current treatment, whichever is longer, as determined by the investigator. This allows the effect of prior therapy to clear before baseline IOP assessment and investigational treatment administration. Participants who are not receiving IOP-lowering therapy at screening, including participants with untreated POAG or OHT, do not require washout. Study-eye clarification: Only one eye per participant is designated as the study eye and receives the assigned intervention. If both eyes otherwise qualify, the eye with the lower visual acuity is selected; if visual acuity is equal in both eyes, the left eye is selected. The fellow non-study eye does not receive the assigned study intervention but is monitored for ocular safety.
Sponsors
Tavo Biotherapeutics Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age more than or equal to 18 years. 2. Diagnosed with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). 3. 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. 4. Intraocular Pressure (IOP) Criteria (study eye): a) 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 IOP compared to the pre-washout measurement. b) 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 minimise variability due to diurnal fluctuation. 5. 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. 6. Adequate ocular clarity and pupillary dilation to permit reliable ophthalmic assessments, including imaging procedures. 7. Female subjects: o Women of Non-Childbearing Potential (WONCBP), or o 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. 8. Male subjects with partners of childbearing potential must agree to use protocol-defined contraception during the study. 9. 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.
Exclusion criteria
1) Ocular conditions that could confound study results, including but not limited to uveitis, macular disease, blepharitis, conjunctivitis, or any active ocular infection or inflammation. 2) History of herpes simplex keratitis. 3) Severe dry eye disease or a clinical diagnosis of Sjögren’s syndrome. 4) Refractive error exceeding a spherical equivalent of more than 6 dioptres or axial length more than 26 mm. 5) Central corneal thickness less than 500 µm or more than 650 µm. 6) Intraocular surgery within 3 months prior to Screening. 7) Ocular trauma within 6 months prior to Screening. 8) 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). 9) Participation in another investigational drug or device study within 6 weeks prior to Screening. 10) Any medical or psychiatric condition that, in the opinion of the investigator, may interfere with study participation, compliance, or interpretation of results. 11) Advanced primary open-angle glaucoma (POAG), defined as a visual field defect score more than 12 on the AGIS scale or a Humphrey Mean Deviation (MD) worse than –12 dB, including subjects with central visual field loss threatening fixation. 12) 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. 13) Known hypersensitivity or contraindication to pregabalin, timolol, beta-blockers, or any component of the study formulations. 14) 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.
Outcome results
None listed