Evaluation of a Novel Ocular Lubricating Eye Drop
ConditionDry Eye Syndrome (DES)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPleryon Therapeutics (Hangzhou) Limited
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Part 2 ABR2 At least twice a day for 28 days
- Part 1: ABR2 single dose in one eye
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Pleryon Therapeutics (Hangzhou) Limited
Lead sponsor
University of Waterloo School of Optometry and Vision Science
Collaborator
Source ClinicalTrials.gov