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0.003% AR-15512 for Dry Eye Syndrome

Phase 3
Waitlist Available
Research Sponsored by Alcon Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Have a previous history of DED, clinician diagnosed or patient reported, within the previous 6 months prior to the Screening visit.
* Have used artificial tears for DED symptoms within 2 months prior to the Screening visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1 pre-instillation), day 90
Awards & highlights

Summary

The purpose of this study is to evaluate the effect of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) on ocular surface characteristics of subjects with dry eye disease (DED).

Who is the study for?
This trial is for individuals with dry eye disease. Participants should have a diagnosis of dry eye syndrome and be willing to follow the study procedures. Specific eligibility criteria are not provided, but typically include age limits, symptom severity, and no recent use of conflicting medications or treatments.
What is being tested?
The study is testing the effectiveness of a new ophthalmic solution called AR-15512 at a concentration of 0.003%. It's being compared against artificial tears, which are commonly used to manage symptoms of dry eye disease.
What are the potential side effects?
While specific side effects for AR-15512 aren't listed here, common side effects for ophthalmic solutions can include temporary discomfort in the eyes, redness, blurred vision, or an allergic reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1 pre-instillation), day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1 pre-instillation), day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage change from baseline in goblet cell density at Day 90

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 0.003% AR-15512Experimental Treatment1 Intervention
One drop in each eye twice daily for 90 days (treatment period)
Group II: Artificial TearsActive Control1 Intervention
One drop in each eye twice daily for 90 days (treatment period)

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Who is running the clinical trial?

Alcon ResearchLead Sponsor
719 Previous Clinical Trials
126,394 Total Patients Enrolled
Clinical Trial Lead, PharmaStudy DirectorAlcon Research, LLC
3 Previous Clinical Trials
610 Total Patients Enrolled
~47 spots leftby May 2025
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