RecruitingNot ApplicableNCT07593404

Evaluation of a Novel Ocular Lubricating Eye Drop

Sponsor

Pleryon Therapeutics (Hangzhou) Limited

Enrollment

40 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Dry Eye Syndrome (DES)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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)

Exclusion Criteria9

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