Evaluation of a Novel Ocular Lubricating Eye Drop

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.

• Part 2 ABR2 At least twice a day for 28 days (Drug): Use ABR2 at least BID, up to QID for 28 days
• Part 1: ABR2 single dose in one eye (Drug): Receive a single dose in one eye only

Primary outcomes

• Number of Adverse Events [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)]: 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.

Other outcomes

• 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)]: Participants will be asked to provide subjective ratings of ocular comfort, stinging/burning sensation and vision based on 0-100 rating scale.
• 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]: Non-invasive tear film break up time (NITBUT) will be performed to examine signs of ocular dryness.
• 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]: Monocular and binocular HCHI VA

Sex: All, ages: 18 Years to any

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

• Charis Lau, PharmD, OD, Study chair, Pleryon Therapeutics
• Jill Woods, MSc, MCOptom, Principal investigator, Centre for Ocular Research & Education, University of Waterloo