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Recruiting NCT07593404

Evaluation of a Novel Ocular Lubricating Eye Drop

No phase Interventional Dry Eye Syndrome (DES)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Part 2 ABR2 At least twice a day for 28 days, Part 1: ABR2 single dose in one eye.
Who it may be relevant to
Registry conditions: Dry Eye Syndrome (DES). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Part 1 has a total of 2 scheduled visits, including Screening and Treatment visit. Participants will attend Part 1 for a total of 3.0 hours.

Part 2 has a total of 6 scheduled visits, including the Screening, baseline \& dispense visit, day 3, 1-week, 2-week, and 4-week Follow Up. Participants will attend Part 2 for a total of 6.5 hours.

Interventions

  • Drug Part 2 ABR2 At least twice a day for 28 days
    Use ABR2 at least BID, up to QID for 28 days
  • Drug Part 1: ABR2 single dose in one eye
    Receive a single dose in one eye only

Primary outcome measures

  • Number of Adverse Events [Time frame: 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)]

Eligibility criteria

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)

Exclusion criteria

  • 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;
  • Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  • Have undergone refractive error surgery or intraocular surgery within the last 12 months;
  • Have any known sensitivity or allergy to the diagnostic sodium fluorescein or to any ingredients in the study product;
  • Are using ocular lubricating eye drops more than twice per day on a typical day over the past month (Part 2 only);
  • Are an employee of the Centre for Ocular Research \& Education directly involved in this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Centre for Ocular Research & Education, School of Optometry & Vision Science, University o — Waterloo

Identifiers

NCT: NCT07593404 · PN251 · P/892/25/PL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗