Evaluation of a Novel Ocular Lubricating Eye Drop

NCT07593404 | Recruiting

• 2 other identifiers: PN251P/892/25/PL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndrome (DES)

Keywords

dry eye syndrome; ophthalmic solution; lubrication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Subjective Ratings of Ocular Comfort, Stinging/Burning Sensation and Vision

  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)

  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

  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

Study Arms (2)

Part 1

EXPERIMENTAL

Part 1 Participants

Drug: Part 1: ABR2 single dose in one eye

Part 2

EXPERIMENTAL

Part 2 Participants

Drug: Part 2 ABR2 At least twice a day for 28 days

Interventions

Part 2 ABR2 At least twice a day for 28 days DRUG

Use ABR2 at least BID, up to QID for 28 days

Part 2

Part 1: ABR2 single dose in one eye DRUG

Receive a single dose in one eye only

Part 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pleryon Therapeutics (Hangzhou) Limited: lead
• University of Waterloo School of Optometry and Vision Science: collaborator

Study Sites (1)

Centre for Ocular Research & Education, School of Optometry & Vision Science, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Charis Lau, PharmD, OD

  Pleryon Therapeutics

  STUDY CHAIR

• Jill Woods, MSc, MCOptom

  Centre for Ocular Research & Education, University of Waterloo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CORE Studies

CONTACT

519-888-4742; corestudies@uwaterloo.ca

Ulli Stahl, PhD

CONTACT

519-888-4742; ustahl@uwaterloo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)