AR-15512 Eye Drops 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

Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms

Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported

Must not have

Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration)

History of ocular surgery within 1 year of the Study Visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, minute 0 (pre-instillation); day 1, minute 3 (post-instillation)

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to see how well a new eye drop called AR-15512 0.003% can increase tear production in people with dry eye disease.

Who is the study for?

This trial is for individuals who have used or wanted to use artificial tears for dry eye symptoms in the last 6 months, have a vision score of 20/200 or better, and overall good eye health. They must not have worn contact lenses or used lid hygiene products within the past week, nor any ocular anti-inflammatory medications within the past month.

What is being tested?

The study tests how well a new ophthalmic solution called AR-15512 (0.003%) increases tear production in people with Dry Eye Disease (DED). Participants will receive an acute dose of this medication to assess its effectiveness.

What are the potential side effects?

While specific side effects are not listed here, potential side effects may include irritation at the site of application, redness, discomfort, or other reactions related to eye drops.

Eligibility Criteria

Inclusion Criteria

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

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I have used or wanted to use artificial tears for dry eyes in the last 6 months.

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I have had dry eye disease in the past year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious eye conditions besides dry eye.

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I have not had eye surgery in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, minute 0 (pre-instillation); day 1, minute 3 (post-instillation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, minute 0 (pre-instillation); day 1, minute 3 (post-instillation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, minute 0 (pre-instillation); day 1, minute 3 (post-instillation) for reporting.