New ocular lubricating eye drop for dry eye relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm study has two parts to evaluate safety and tolerability of ABR2. Part 1 administers a single eye drop and monitors effects over one hour. Part 2 uses ABR2 at least twice daily for 28 days, with follow-up visits through Week 4 to assess ongoing safety and tolerability in adults with dry eye syndrome. No placebo or comparator is used, and eligibility requires sufficient vision, dry eye symptoms, and compliance with study procedures.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre for Ocular Research & Education, School of Optometry & Vision Science, University of Waterloo
  Waterloo, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Jill Woods, MSc, MCOptom — Centre for Ocular Research & Education, University of Waterloo
• Study coordinator: CORE Studies
• Email: corestudies@uwaterloo.ca
• Phone: 519-888-4742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.