Evaluation of a Novel Ocular Lubricating Eye Drop (DRAGON)

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Syndrome (DES)
• Intervention / Treatment: Drug: Part 1: ABR2 single dose in one eye; Drug: Part 2 ABR2 At least twice a day for 28 days

Detailed Description

Part 1 has a total of 2 scheduled visits, including Screening and Treatment visit. Participants will attend Part 1 for a total of 3.0 hours.

Part 2 has a total of 6 scheduled visits, including the Screening, baseline & dispense visit, day 3, 1-week, 2-week, and 4-week Follow Up. Participants will attend Part 2 for a total of 6.5 hours.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CORE Studies; Phone Number: 519-888-4742; Email: corestudies@uwaterloo.ca
• Study Contact Backup: Name: Ulli Stahl, PhD; Phone Number: 519-888-4742; Email: ustahl@uwaterloo.ca

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Recruiting
      • Centre for Ocular Research & Education, School of Optometry & Vision Science, University of Waterloo
      • Principal Investigator: Jill Woods, MSc, MCOptom
      • Contact: CORE Studies; Phone Number: 519-888-4742; Email: corestudies@uwaterloo.ca
      • Contact: Ulli Stahl, PhD; Phone Number: 519-888-4742; Email: ustahl@uwaterloo.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; Part 1 Participants	Drug: Part 1: ABR2 single dose in one eye; Receive a single dose in one eye only
Experimental: Part 2; Part 2 Participants	Drug: Part 2 ABR2 At least twice a day for 28 days; Use ABR2 at least BID, up to QID for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events	Number of adverse events associated with the use of ocular eye drop. Example of adverse events may include, severe conjunctival and palpebral hyperemia, hypersensitivity, allergic reaction, eyelid edema, and photophobia.	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Ratings of Ocular Comfort, Stinging/Burning Sensation and Vision	Participants will be asked to provide subjective ratings of ocular comfort, stinging/burning sensation and vision based on 0-100 rating scale.	Part 1: Immediately after drop instillation, 10 minutes, 30 minutes and 60 minutes post drop instillation. Part 2: Upon waking and at the end of day weekly for 4 weeks (Home Questionnaire)
Signs of ocular dryness - Non-invasive tear film break up time (NITBUT)	Non-invasive tear film break up time (NITBUT) will be performed to examine signs of ocular dryness.	Part 1: Baseline and 60 minutes after a drop of ABR2 application. Part 2: Baseline, 2 week, and 4 week after ABR2 use
High Contrast High Luminance (HCHI) LogMAR Visual Acuity	Monocular and binocular HCHI VA	Part 1: Baseline, immediate, 5 minutes, 10 minutes, 30 minutes and 60 minutes after drop application Part 2: Baseline, day 3, 1-week, 2-week and 4-week follow up

Collaborators and Investigators

• Sponsor: Pleryon Therapeutics (Hangzhou) Limited
• Collaborators: University of Waterloo School of Optometry and Vision Science
• Investigators: Study Chair: Charis Lau, PharmD, OD, Pleryon Therapeutics; Principal Investigator: Jill Woods, MSc, MCOptom, Centre for Ocular Research & Education, University of Waterloo

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: lubrication; ophthalmic solution; dry eye syndrome
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: PN251; P/892/25/PL (Other Identifier: Centre for Ocular Research & Education)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Small sample size re-identification risk and limited infrastructure for external data access.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No