Evaluation of a Novel Ocular Lubricating Eye Drop

Recruiting now · Not applicable

Conditions studied: Dry Eye Syndrome (DES)

In brief

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.

Key facts

Study ID

NCT07593404

Run by

Pleryon Therapeutics (Hangzhou) Limited

People needed

40

Starts

2026-05-01

Expected to finish

2027-05-01

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are at least 18 years of age and have capacity to volunteer
• Are able to read (Part 2 only);
• Have signed an information and consent letter;
• Are willing to follow instructions and maintain the appointment schedule;
• Are willing to refrain from contact lens wear throughout the study period;
• Have a best corrected visual acuity of +0.20 LogMAR or better in each eye;
• 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)

You may not qualify if…

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

Where it is running

• Centre for Ocular Research & Education, School of Optometry & Vision Science, University of Waterloo — Waterloo, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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