Recruiting

ABR2

Sponsor:

Pleryon Therapeutics (Hangzhou) Limited

Code:

NCT07593404

Conditions

Dry Eye Syndrome (DES)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Part 2 ABR2 At least twice a day for 28 days

Part 1: ABR2 single dose in one eye

Study Details

Brief summary:

The objective of this 2-part study is to assess the safety and tolerability of the new ocular lubricating drop ABR2 during short-term use in subjects for the temporary relief of ocular discomfort due to dryness of the eye.

In Part 1, participant will receive 1 drop of ABR2 in one eye and through assessments over a 1-hour period.

In Part 2, participant will use 1 drop of ABR2 at least two times a day for 28-day period (may use up to 4 times a day as needed) This is a single arm, open label study with no placebo or comparative arm.

Conditions

Dry Eye Syndrome (DES)

Study ID

NCT07593404

Start date

May, 2026

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Are at least 18 years of age and have capacity to volunteer
2. Are able to read (Part 2 only);
3. Have signed an information and consent letter;
4. Are willing to follow instructions and maintain the appointment schedule;
5. Are willing to refrain from contact lens wear throughout the study period;
6. Have a best corrected visual acuity of +0.20 LogMAR or better in each eye;
7. Have an OSDI score ≥13 AND at least one of the following signs in at least one eye: Non-invasive tear film break-up time (NITBUT) < 10 sec, AND/OR ocular surface staining (> 5 corneal spots, and/ or > 9 conjunctival spots)

Exclusion Criteria:

1. Participation in another ocular clinical research study or pharmaceutical clinical study within the past 14 days;
2. Have a known active ocular disease and/ or infection with the exception of dry eye disease;
3. Have any slit lamp findings that would contraindicate use of the study product;
4. Have a systemic condition that would contraindicate use of the study product;
5. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
6. Have undergone refractive error surgery or intraocular surgery within the last 12 months;
7. Have any known sensitivity or allergy to the diagnostic sodium fluorescein or to any ingredients in the study product;
8. Are using ocular lubricating eye drops more than twice per day on a typical day over the past month (Part 2 only);
9. Are an employee of the Centre for Ocular Research \& Education directly involved in this study

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1

Part 1 Participants

experimental: Part 2

Part 2 Participants

Interventions

Part 2 ABR2 At least twice a day for 28 days

Use ABR2 at least BID, up to QID for 28 days

Part 1: ABR2 single dose in one eye

Receive a single dose in one eye only

Primary outcome measure

  • Number of Adverse Events [ Time Frame: At the end of Part 1: 60 minutes after single drop monocular instillation and At the end of Part 2 (after 28 days of bilateral use) ]

Central Contacts and Locations

Locations

Centre for Ocular Research & Education, School of Optometry & Vision Science, University of Waterloo

Recruiting

Waterloo, Ontario, Canada, N2L 3G1

Contacts

Principal Investigator:

Jill Woods, MSc, MCOptom

More Information

Sponsor

Pleryon Therapeutics (Hangzhou) Limited

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • dry eye syndrome
  • ophthalmic solution
  • lubrication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pleryon Therapeutics (Hangzhou) Limited on 2026-05-19.