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AR-15512 for Dry Eye Syndrome

Phase 3
Recruiting
Research Sponsored by Alcon Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
History of ocular surgery within 1 year prior to the Screening visit; history of corneal transplant in one or both eyes
Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1 pre-instillation), day 90
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial aims to see how a certain eye drops called AR-15512 0.003% can help improve the eye surface of people with dry eye disease.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had eye surgery or a corneal transplant in the last year.
Select...
I haven't worn contact lenses in the last 7 days and won't during the study.

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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)

Find a Location

Who is running the clinical trial?

Alcon ResearchLead Sponsor
732 Previous Clinical Trials
128,783 Total Patients Enrolled
Clinical Trial Lead, PharmaStudy DirectorAlcon Research, LLC
3 Previous Clinical Trials
610 Total Patients Enrolled
~42 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
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