NCT07593404 Evaluation of a Novel Ocular Lubricating Eye Drop
| NCT ID | NCT07593404 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pleryon Therapeutics (Hangzhou) Limited |
| Condition | Dry Eye Syndrome (DES) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-05 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-05 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Charis Lau, PharmD, OD
STUDY CHAIR
Pleryon Therapeutics
Frequently Asked Questions
Who can join the NCT07593404 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dry Eye Syndrome (DES). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07593404 currently recruiting?
Yes, NCT07593404 is actively recruiting participants. Contact the research team at corestudies@uwaterloo.ca for enrollment information.
Where is the NCT07593404 trial being conducted?
This trial is being conducted at Waterloo, Canada.
Who is sponsoring the NCT07593404 clinical trial?
NCT07593404 is sponsored by Pleryon Therapeutics (Hangzhou) Limited. The principal investigator is Charis Lau, PharmD, OD at Pleryon Therapeutics. The trial plans to enroll 40 participants.