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RecruitingNCT07913074Updated Nov 3, 2026

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 interventional study of Arm 1: TB0001 ophthalmic solution 0.9% and Arm 2: TB0001 ophthalmic solution 1.2% in Primary Open - Angle Glaucoma (POAG) and Ocular Hypertension (OHT), sponsored by Tavo Biotherapeutics. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Tavo Biotherapeutics · Phase 2, Interventional, and Treatment

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Open - Angle Glaucoma (POAG)
  • Ocular Hypertension (OHT)

Keywords

  • Glaucoma
  • Intraocular pressure
  • Primary Open-Angle Glaucoma
  • Ocular Hypertension
03

In context

Glaucoma, Open-Angle

944 studies on the registry are indexed under Glaucoma, Open-Angle; 118 are open to participants now.

This study's planned enrollment of 96 is above the median of 80 across 711 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

This is the only study on the registry with Tavo Biotherapeutics as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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):

    1. 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.

    2. 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.

  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:

    • 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.
  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

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 26mm.
  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 month 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    Arm 1: Pregabalin Ophthalmic solution (TB0001) 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.

    Drug: Arm 1: TB0001 ophthalmic solution 0.9%

  • Experimental
    Arm 2: Pregabalin ophthalmic solution (TB0001) 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.

    Drug: Arm 2: TB0001 ophthalmic solution 1.2%

  • Experimental
    Arm 3: Pregabalin ophthalmic solution (TB0001) 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.

    Drug: TB0001 ophthalmic solution 1.5%

  • Active comparator
    Arm 4: Timolol ophthalmic solution 0.5%

    The comparator product is timolol maleate ophthalmic solution 0.5%. It will be administered twice daily (AM + PM)

    Drug: Timolol 0.05% eye drops

Interventions

  • DrugArm 1: TB0001 ophthalmic solution 0.9%

    TB0001 is a sterile, clear colorless to slightly yellow pregabalin ophthalmic solution at concentrations of 0.9%

  • DrugArm 2: TB0001 ophthalmic solution 1.2%

    Pregabalin ophthalmic solution (TB0001) 1.2% is a sterile, colorless to slightly yellow solution.

  • DrugTB0001 ophthalmic solution 1.5%

    TB0001 is a sterile, clear, colorless to slightly yellow solution

  • DrugTimolol 0.05% eye drops

    Timolol ophthalmic solution 0.5% will be administered twice daily (AM + PM)

06

What researchers measure

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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.

    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

  2. Proportion of participants achieving at least 20% reduction in intraocular pressure from baseline

    Goldmann Applanation Tonometry.

    Time frame: Day 1, Day 3, Day 7, Day 14 and Day 28 post treatment

  3. 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.

    Time frame: Day 1, Day 3, Day 7, Day 14 and Day 28 post treatment

  4. Incidence and severity of treatment-emergent adverse events as composite outcome

    Adverse event reporting, clinical assessment and safety monitoring as composite outcome

    Time frame: From randomization (Day -1) until the end of study (Day 28) post treatment

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07913074
Lead sponsor
Tavo Biotherapeutics
Collaborators
True North Therapeutics
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Oct 23, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Joel Thompson
Contact
Joel@tavobio.com
+1(605) 310 3356
Lukas Scheibler, PhD
study chair · Tavo Biotherapeutics, Inc

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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