Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000766415
Ethics application status
Approved
Date submitted
2/07/2025
Date registered
18/07/2025
Date last updated
18/07/2025
Date data sharing statement initially provided
18/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pregabalin (PRG) ophthalmic solutions in patients diagnosed with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Scientific title
Phase 1, randomized, single-masked, multiple ascending dose (MAD) study designed to evaluate the safety, tolerability, and preliminary efficacy of pregabalin (PRG) ophthalmic solutions in patients diagnosed with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Secondary ID [1] 314803 0
TAV001-C101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Open-Angle Glaucoma (POAG) 338053 0
Ocular Hypertension (OHT) 338054 0
Condition category
Condition code
Eye 334348 334348 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a Phase 1, randomized, single-masked, multiple ascending dose (MAD) study designed to evaluate the safety, tolerability, and preliminary efficacy of pregabalin (PRG) ophthalmic solution (TB0001-EAP05) in patients diagnosed with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OHT). This study aims to determine the safety profile of pregabalin eye drops and to explore its effects on Intraocular Pressure (IOP) and corneal sensitivity over a three-day treatment period.
The study will be conducted at up to 3 clinical sites and will include up to 32 participants, divided into 4 escalating dose cohorts (8 participants per cohort, 6 receiving TB0001-EAP05):
• Cohort 1: 3 mg/mL
• Cohort 2: 6 mg/mL (provisional)
• Cohort 3: 12 mg/mL (provisional)
• Cohort 4: 20mg/mL (provisional)
The doses for Cohorts 2-4 are provisional and will be adjusted based on safety, tolerability, and emerging IOP-lowering data..
The study is divided into four phases:
Screening Phase occurs at least 14 days but not more than 60 days prior to Baseline Visit (Visit 2) to confirm eligibility and baseline ocular and systemic health.
Washout Period for participants currently receiving topical IOP-lowering medications at screening will be required to undergo a washout period of 14 to 28 days, or a duration equivalent to at least five pharmacologic half-lives of their existing IOP-lowering agent(s), whichever is longer. This is to ensure complete clearance of drug effect prior to baseline IOP assessment and investigational product dosing. Participants who are not on any IOP-lowering therapy at screening (e.g., untreated OHT or POAG) are exempt from this requirement.
Baseline and Treatment Phase: where participants will be randomized within each cohort in a 6:2 ratio. 6 participants in all dose cohort will receive TB0001-EAP05 topically as a 35 µL dose on site once daily for three consecutive days, followed by post-treatment assessments to evaluate safety and pharmacodynamic effects. The volume of intervention remains the same for each dose cohort, with the concentration being adjusted.
Post-Treatment Phase where a comprehensive safety and efficacy evaluation will be conducted on 4 days post first dose at the clinical site.
Each participant will participate in the trial for up to 64 days.
Adherence to the intervention is monitored by study staff as the intervention is only given on site.
Intervention code [1] 331401 0
Treatment: Drugs
Comparator / control treatment
Xalatan 0.005% eye drops (LATANOPROST OPHTHALMIC SOLUTION), 50 µg/mL given as a 35 µL drop once daily for 3 days.
Adherence to the control treatment is monitored by study staff as the control treatment is only given on site.
Control group
Active

Outcomes
Primary outcome [1] 342034 0
To evaluate the safety and tolerability of increasing doses of pregabalin eye drops when administered once daily for three days. (Composite Outcome)
Timepoint [1] 342034 0
Baseline and Day 4 post intervention commencement
Secondary outcome [1] 449379 0
To evaluate the changes in corneal sensitivity between baseline and Day 3
Timepoint [1] 449379 0
Baseline and Day 3 post intervention commencement
Secondary outcome [2] 449380 0
To evaluate the changes in Intraocular Pressure (IOP)
Timepoint [2] 449380 0
Baseline, before treatment administration, 1 hours post-treatment, 3 hours post-treatment, 6 hours post-treatment, and 23.5 hours post-treatment

Eligibility
Key inclusion criteria
1. Age more than or equal to 40 years.
2. Diagnosed with mild to moderate POAG or OHT, treated with less than or equal to 2 IOP-lowering medications.
o Participants with POAG must have a visual field defect score of less than 12 on the AGIS scale
3. IOP Criteria (of study eye):
o At screening (before washout): less than 24 mmHg.
o At baseline (after washout): 22-34 mmHg.
Note: Participants who are not currently using IOP-lowering therapy (i.e., untreated OHT or POAG) are exempt from washout and may proceed directly to Baseline if all other criteria are met.
4. Willing and able to discontinue existing IOP-lowering medication(s) and undergo a washout period of 14 to 28 days, or more than or equal to 5 pharmacologic half-lives of the current agent(s), as determined by the investigator.
5. Adequate ocular clarity and pupillary dilation for imaging.
6. Female subjects:
o Women of Non-Childbearing Potential (WONCBP) or
o Women of Childbearing Potential (WOCBP) with a negative serum pregnancy test and use of protocol-defined contraception.
7. Males with female partners must agree to protocol-defined contraception.
8. Willing and able to provide informed consent
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ocular conditions that could confound results:
o Uveitis, macular diseases, blepharitis, conjunctivitis.
o History of herpes simplex keratitis.
o Spherical equivalent more than 6 diopters or axial length more than 26mm (for clarity: measuring only one parameter as part of determining eligibility is acceptable)
2. Central corneal thickness less than 500 micrometres or more than 650 micrometres.
3. Recent intraocular surgery (within 3 months).
4. Ocular trauma (within 6 months).
5. Use of systemic calcium channel blockers.
6. Participation in another investigational drug trial within 6 weeks.
7. Medical or psychiatric conditions may affect compliance.
8. Advanced Primary Open-Angle Glaucoma (POAG), defined as a visual field defect score more than or equal to 12 on the Advanced Glaucoma Intervention Study (AGIS) scale. This includes participants with central visual field loss threatening fixation, due to the increased risk of functional deterioration during washout and investigational treatment.
o Participants for whom washout of IOP-lowering therapy is deemed unsafe, including those with:
• History of uncontrolled IOP rebound during treatment withdrawal
• Optic nerve cupping progression related to prior washout attempts
• Any other condition where IOP elevation during washout would pose undue risk, in the opinion of the investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple central randomisation by computer that is stratified by sites
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
8/10/2027
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319359 0
Commercial sector/Industry
Name [1] 319359 0
Tavo Biotherapeutics
Country [1] 319359 0
United States of America
Funding source category [2] 319357 0
Commercial sector/Industry
Name [2] 319357 0
Ingenu CRO Pty. Ltd
Country [2] 319357 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Tavo Biotherapeutics
Address
Country
United States of America
Secondary sponsor category [1] 321844 0
Commercial sector/Industry
Name [1] 321844 0
Ingenu CRO Pty. Ltd
Address [1] 321844 0
Country [1] 321844 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317935 0
Bellberry Human Research Ethics Committee G
Ethics committee address [1] 317935 0
Ethics committee country [1] 317935 0
Australia
Date submitted for ethics approval [1] 317935 0
07/05/2025
Approval date [1] 317935 0
24/06/2025
Ethics approval number [1] 317935 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142614 0
Dr Helen Chan
Address 142614 0
Eye Surgery Associates, Level 2, 232 Victoria Parade, VIC 3002
Country 142614 0
Australia
Phone 142614 0
+610394160695
Fax 142614 0
Email 142614 0
[email protected]
Contact person for public queries
Name 142615 0
Darryl Davies
Address 142615 0
iNGENu CRO, Unit 22/456 St Kilda Rd, Melbourne VIC 3004
Country 142615 0
Australia
Phone 142615 0
+611300633226
Fax 142615 0
Email 142615 0
[email protected]
Contact person for scientific queries
Name 142616 0
Darryl Davies
Address 142616 0
iNGENu CRO, Unit 22/456 St Kilda Rd, Melbourne VIC 3004
Country 142616 0
Australia
Phone 142616 0
+611300633226
Fax 142616 0
Email 142616 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.