Evaluation of a Novel Ocular Lubricating Eye Drop
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.
• 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)