BridgeMD
New treatment option for Dry Eye Syndrome (DES)
Official title Evaluation of a Novel Ocular Lubricating Eye Drop
ClinicalTrials.gov ID: NCT07593404
What this study is testing
What is Part 2 ABR2 At least twice a day for 28 days?
Part 2 ABR2 At least twice a day for 28 days is an investigational medicine, being studied as a potential treatment for dry eye syndrome (des).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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) \ 5 corneal spots, and/ or \> 9 conjunctival spots)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Waterloo, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Waterloo, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.