ABR2 Eye Drops for Dry Eye

(DRAGON Trial)

Overseen By Ulli Stahl, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pleryon Therapeutics (Hangzhou) Limited

Must not be taking: Systemic medications

Disqualifiers: Active ocular disease, Recent eye surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Charis Lau, PharmD, OD

Principal Investigator

Pleryon Therapeutics

Jill Woods, MSc, MCOptom

Principal Investigator

Centre for Ocular Research & Education, University of Waterloo

Are You a Good Fit for This Trial?

This trial is for people with dry eye symptoms who are seeking temporary relief. Participants should not have any major eye diseases or conditions that could interfere with the study, and must be able to follow instructions for using the eye drops.

Inclusion Criteria

Have signed an information and consent letter

I am at least 18 years old and able to make my own decisions.

Are able to read (Part 2 only)

Exclusion Criteria

Participation in another ocular clinical research study or pharmaceutical clinical study within the past 14 days

I do not have any eye exam results that prevent me from using the study product.

I am not taking any medications that could affect the study results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Part 1: 1 visit, Part 2: 1 visit

1 visit (in-person)

Treatment Part 1

Participants receive 1 drop of ABR2 in one eye with assessments over a 1-hour period

1 hour

1 visit (in-person)

Treatment Part 2

Participants use 1 drop of ABR2 at least two times a day for 28 days

28 days

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ABR2

Trial Overview

The study tests a new lubricating eye drop called ABR2. In Part 1, participants get a single dose in one eye; in Part 2, they use the drops at least twice daily for 28 days. There is no comparison group—everyone receives ABR2.

How Is the Trial Designed?

Group I: Part 2 Experimental Treatment 1 Intervention

Part 2 Participants

Group II: Part 1 Experimental Treatment 1 Intervention

Part 1 Participants

Who Is Running the Clinical Trial?

Pleryon Therapeutics (Hangzhou) Limited

Lead Sponsor

University of Waterloo School of Optometry and Vision Science

Collaborator

Trials

1

Recruited

150+