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Evaluation of a Novel Ocular Lubricating Eye Drop

RecruitingNAAges 18 Years - anyAllPleryon Therapeutics (Hangzhou) Limited
NCT07593404 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • Part 2 ABR2 At least twice a day for 28 days
  • Part 1: ABR2 single dose in one eye
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Where

1 site
Centre for Ocular Research & Education, School of Optometry & Vision Science, University of Waterloo
Waterloo, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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