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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1 pre-instillation), day 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1 pre-instillation), day 90
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)
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Who is running the clinical trial?
Alcon ResearchLead Sponsor
731 Previous Clinical Trials
128,833 Total Patients Enrolled
Clinical Trial Lead, PharmaStudy DirectorAlcon Research, LLC
3 Previous Clinical Trials
610 Total Patients Enrolled
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