Trial · NCT07913074
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.
NCT07913074, Phase 2, Recruiting, Tavo Biotherapeutics
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. 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. Trials, record NCT07913074. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07913074
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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.
- NCT number
- NCT07913074
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 96 participants, estimated
- Lead sponsor
- Tavo Biotherapeutics
- Conditions
- Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
- Interventions
- Arm 1: TB0001 ophthalmic solution 0.9%, Arm 2: TB0001 ophthalmic solution 1.2%, TB0001 ophthalmic solution 1.5%, Timolol 0.05% eye drops
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from mean diurnal baseline IOP to mean diurnal IOP at Day 28 | 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. |
| Secondary | 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. | 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 | 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. |
| Secondary | Proportion of participants achieving at least 20% reduction in intraocular pressure from baseline | Day 1, Day 3, Day 7, Day 14 and Day 28 post treatment | Goldmann Applanation Tonometry. |
| Secondary | 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 | Day 1, Day 3, Day 7, Day 14 and Day 28 post treatment | 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. |
| Secondary | Incidence and severity of treatment-emergent adverse events as composite outcome | From randomization (Day -1) until the end of study (Day 28) post treatment | Adverse event reporting, clinical assessment and safety monitoring as composite outcome |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07913074
GET https://conductscience.org/api/trials/v1/NCT07913074/registered