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.

Inclusion criteria

• 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)

Exclusion criteria

• 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