Primary Open - Angle Glaucoma (POAG)Phase 2NCT07913074
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.
A Phase 2 study testing Arm 1: TB0001 ophthalmic solution 0.9%, Arm 2: TB0001 ophthalmic solution 1.2% and TB0001 ophthalmic solution 1.5% in people with Primary Open - Angle Glaucoma (POAG) and Ocular Hypertension (OHT), run by Tavo Biotherapeutics at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
- What is being tested?
- Arm 1: TB0001 ophthalmic solution 0.9%, Arm 2: TB0001 ophthalmic solution 1.2% and TB0001 ophthalmic solution 1.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Oct 2026to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 subjects with central visual field loss threatening fixation.
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Global Research Management, Inc
Glendale, California, 91204
- Recruiting
Piedmont Eye Center
Lynchburg, Virginia, 24502
- Recruiting
Eye Research Foundation, Inc
Newport Beach, California, 92663
About this study
Official title: A Phase 2a, Randomized, Double-Masked, Double-Dummy, Parallel-Group Study to Evaluate the Intraocular Pressure (IOP)-Lowering Efficacy, Safety, and Tolerability of TB0001 (Pregabalin Ophthalmic Solution) Compared With Timolol 0.5% In Subjects With Primary Open-Angle Glaucoma (POAG) Or Ocular Hypertension (OHT)
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.
- Being tested
- Arm 1: TB0001 ophthalmic solution 0.9%, Arm 2: TB0001 ophthalmic solution 1.2%, TB0001 ophthalmic solution 1.5%, Timolol 0.05% eye drops
- Keywords
- Glaucoma, Intraocular pressure, Primary Open-Angle Glaucoma, Ocular Hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: TB0001 ophthalmic solution 0.9%Drug
TB0001 is a sterile, clear colorless to slightly yellow pregabalin ophthalmic solution at concentrations of 0.9%
Arm 2: TB0001 ophthalmic solution 1.2%Drug
Pregabalin ophthalmic solution (TB0001) 1.2% is a sterile, colorless to slightly yellow solution.
TB0001 ophthalmic solution 1.5%Drug
TB0001 is a sterile, clear, colorless to slightly yellow solution
Timolol 0.05% eye dropsDrug
Timolol ophthalmic solution 0.5% will be administered twice daily (AM + PM)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Pregabalin Ophthalmic solution (TB0001) 0.9% | Experimental | Pregabalin ophthalmic solution (TB0001) 0.9% administered as one drop in the study eye once daily in the morning for 28 days. Participants also administer a matching vehicle ophthalmic solution as one drop into the study eye once daily in the evening as part of the double-dummy design to maintain masking. Receives: Drug: Arm 1: TB0001 ophthalmic solution 0.9% |
| Arm 2: Pregabalin ophthalmic solution (TB0001) 1.2% | Experimental | Pregabalin ophthalmic solution (TB0001) 1.2% administered as one drop in the study eye once daily in the morning for 28 days. Participants also administer a matching vehicle ophthalmic solution as one drop into the study eye once daily in the evening as part of the double-dummy design to maintain masking. Receives: Drug: Arm 2: TB0001 ophthalmic solution 1.2% |
| Arm 3: Pregabalin ophthalmic solution (TB0001) 1.5% | Experimental | Pregabalin ophthalmic solution (TB0001) 1.5% administered as one drop in the study eye once daily in the morning for 28 days. Participants also administer a matching vehicle ophthalmic solution as one drop into the study eye once daily in the evening as part of the double-dummy design to maintain masking. Receives: Drug: TB0001 ophthalmic solution 1.5% |
| Arm 4: Timolol ophthalmic solution 0.5% | Active comparator | The comparator product is timolol maleate ophthalmic solution 0.5%. It will be administered twice daily (AM + PM) Receives: Drug: Timolol 0.05% eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from mean diurnal baseline IOP to mean diurnal IOP at Day 28
Goldmann Applanation Tonometry. Duplicate intraocular pressure measurements are obtained at each timepoint. Mean diurnal intraocular pressure is calculated as the average of the approximately 1-, 3-, and 6-hour post-dose measurements.
Measured: Baseline (pre-treatment) and Day 28 (approximately 1, 3 and 6 hours after the morning study treatment administration; primary timepoint). Baseline mean diurnal intraocular pressure is calculated from measurements obtained prior to treatment initiation.
Secondary outcomes (4)
Change from mean diurnal baseline IOP to mean diurnal IOP at Days 3 and 14; and change from mean diurnal baseline IOP to 3-hour post-dose IOP at Days 1 and 7.
Goldmann Applanation Tonometry. Duplicate intraocular pressure measurements are obtained at eachassessment. Mean diurnal intraocular pressure is calculated as the average of the approximately 1-, 3-, and6-hour post-dose measurements where applicable.
Measured: Baseline (pre-treatment), Day 1 (approximately 3 hours after morning study treatment), Day 3(approximately 1, 3 and 6 hours after morning study treatment), Day 7 (approximately 3 hours after morning study treatment), and Day 14 (approximately 1, 3 and 6
Proportion of participants achieving at least 20% reduction in intraocular pressure from baseline
Goldmann Applanation Tonometry.
Measured: Day 1, Day 3, Day 7, Day 14 and Day 28 post treatment
Ocular symptom and ocular sign scores - Change from baseline in conjunctival hyperaemia score following study treatment. Conjunctival hyperaemia (redness of the conjunctiva) will be assessed independently by the investigator
Participant-reported ocular symptom assessment using the protocol-defined standardized 4-point ordinal scale (0-3). This scale was designed specifically for this study.
Investigator assessment of conjunctival hyperaemia during slit-lamp examination using the protocol-defined grading scale and standardised photographic reference scale. This scale was designed specificallyfor this study.
Measured: Day 1, Day 3, Day 7, Day 14 and Day 28 post treatment
Incidence and severity of treatment-emergent adverse events as composite outcome
Adverse event reporting, clinical assessment and safety monitoring as composite outcome
Measured: From randomization (Day -1) until the end of study (Day 28) post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start23 Oct 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open - Angle Glaucoma (POAG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ph 2a, randomized, double-masked, double-dummy, parallel -group, multi-center study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tavo Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- True North Therapeutics
- Responsible party
- Sponsor
- Investigators
- Lukas Scheibler, PhD, Study chair, Tavo Biotherapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913074
- Sponsor's protocol ID
- TAV001-C201
- Other IDs
- NDA 022488
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Masked, Double-Dummy, Parallel-Group Study to Evaluate the Intraocular Pressure (IOP)-Lowering Efficacy, Safety, and Tolerability of TB0001 (Pregabalin Ophthalmic Solution) Compared With Timolol 0.5% In Subjects With Primary Open-Angle Glaucoma (POAG) Or Ocular Hypertension (OHT)
- ClinicalTrials.gov ID
- NCT07913074
- Acronym / sponsor ID
- TAV001-C201
- Keywords
- Glaucoma, Intraocular pressure, Primary Open-Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Tavo BiotherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- True North Therapeutics
- Study start
- 23 Oct 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Ph 2a, randomized, double-masked, double-dummy, parallel -group, multi-center study
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Pregabalin Ophthalmic solution (TB0001) 0.9% | Experimental | Drug: Arm 1: TB0001 ophthalmic solution 0.9%Pregabalin ophthalmic solution (TB0001) 0.9% administered as one drop in the study eye once daily in the morning for 28 days. Participants also administer a matching vehicle ophthalmic solution as one drop into the study eye once daily in the evening as part of the double-dummy design to maintain masking. |
| Arm 2: Pregabalin ophthalmic solution (TB0001) 1.2% | Experimental | Drug: Arm 2: TB0001 ophthalmic solution 1.2%Pregabalin ophthalmic solution (TB0001) 1.2% administered as one drop in the study eye once daily in the morning for 28 days. Participants also administer a matching vehicle ophthalmic solution as one drop into the study eye once daily in the evening as part of the double-dummy design to maintain masking. |
| Arm 3: Pregabalin ophthalmic solution (TB0001) 1.5% | Experimental | Drug: TB0001 ophthalmic solution 1.5%Pregabalin ophthalmic solution (TB0001) 1.5% administered as one drop in the study eye once daily in the morning for 28 days. Participants also administer a matching vehicle ophthalmic solution as one drop into the study eye once daily in the evening as part of the double-dummy design to maintain masking. |
| Arm 4: Timolol ophthalmic solution 0.5% | Active comparator | Drug: Timolol 0.05% eye dropsThe comparator product is timolol maleate ophthalmic solution 0.5%. It will be administered twice daily (AM + PM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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):
- Note: All screening IOP assessments must be conducted at 8:30am ± 1 hour to minimize variability due to diurnal fluctuation.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1: TB0001 ophthalmic solution 0.9%TB0001 is a sterile, clear colorless to slightly yellow pregabalin ophthalmic solution at concentrations of 0.9% | Drug | Arm 1: Pregabalin Ophthalmic solution (TB0001) 0.9% |
| Arm 2: TB0001 ophthalmic solution 1.2%Pregabalin ophthalmic solution (TB0001) 1.2% is a sterile, colorless to slightly yellow solution. | Drug | Arm 2: Pregabalin ophthalmic solution (TB0001) 1.2% |
| TB0001 ophthalmic solution 1.5%TB0001 is a sterile, clear, colorless to slightly yellow solution | Drug | Arm 3: Pregabalin ophthalmic solution (TB0001) 1.5% |
| Timolol 0.05% eye dropsTimolol ophthalmic solution 0.5% will be administered twice daily (AM + PM) | Drug | Arm 4: Timolol ophthalmic solution 0.5% |
Primary outcome
Change from mean diurnal baseline IOP to mean diurnal IOP at Day 28
Time frame: Baseline (pre-treatment) and Day 28 (approximately 1, 3 and 6 hours after the morning study treatment administration; primary timepoint). Baseline mean diurnal intraocular pressure is calculated from measurements obtained prior to treatment initiation.
Goldmann Applanation Tonometry. Duplicate intraocular pressure measurements are obtained at each timepoint. Mean diurnal intraocular pressure is calculated as the average of the approximately 1-, 3-, and 6-hour post-dose measurements.
4 secondary outcomes
Change from mean diurnal baseline IOP to mean diurnal IOP at Days 3 and 14; and change from mean diurnal baseline IOP to 3-hour post-dose IOP at Days 1 and 7.
Time frame: Baseline (pre-treatment), Day 1 (approximately 3 hours after morning study treatment), Day 3(approximately 1, 3 and 6 hours after morning study treatment), Day 7 (approximately 3 hours after morning study treatment), and Day 14 (approximately 1, 3 and 6
Proportion of participants achieving at least 20% reduction in intraocular pressure from baseline
Time frame: Day 1, Day 3, Day 7, Day 14 and Day 28 post treatment
Ocular symptom and ocular sign scores - Change from baseline in conjunctival hyperaemia score following study treatment. Conjunctival hyperaemia (redness of the conjunctiva) will be assessed independently by the investigator
Time frame: Day 1, Day 3, Day 7, Day 14 and Day 28 post treatment
Incidence and severity of treatment-emergent adverse events as composite outcome
Time frame: From randomization (Day -1) until the end of study (Day 28) post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lukas Scheibler, PhD study chair
Tavo Biotherapeutics, Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arm 1: TB0001 ophthalmic solution 0.9%, Arm 2: TB0001 ophthalmic solution 1.2% and TB0001 ophthalmic solution 1.5% in people with Primary Open - Angle Glaucoma (POAG) and Ocular Hypertension (OHT), run by Tavo Biotherapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joel Thompson (+1(605) 310 3356, Joel@tavobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from mean diurnal baseline IOP to mean diurnal IOP at Day 28 (time frame: Baseline (pre-treatment) and Day 28 (approximately 1, 3 and 6 hours after the morning study treatment administration; primary timepoint). Baseline mean diurnal intraocular pressure is calculated from measurements obtained prior to treatment initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.