Evaluation of a Novel Ocular Lubricating Eye Drop (NCT07593404) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of a Novel Ocular Lubricating Eye Drop
Canada40 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is measuring the number of adverse events as its primary outcome, does that mean the main goal is to evaluate safety rather than whether my dry eye symptoms actually improve, and what does that mean for me as a participant?
2This trial appears to be in an early or unclassified phase focused on safety monitoring — given where I am with my dry eye symptoms, would it make more sense to try established lubricating eye drops first before considering an experimental one?
3What specific adverse events would the researchers be watching for during this trial, and how would any problems be caught and managed if they occur?
4How does participating in this trial fit with any other dry eye treatments I'm currently using or considering — would I need to stop my current eye drops to take part?
5If I join this trial and experience side effects or decide it's not working for me, what are my options for switching to a standard dry eye treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Adverse Events
Timeframe: 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)