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AR-15512 Ophthalmic Solution for Dry Eye Syndrome
Phase 3
Waitlist Available
Research Sponsored by Aerie Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7, 14, 28 & 90
Awards & highlights
Pivotal Trial
Summary
This trial tests a new treatment for dry eye disease. It involves patients who suffer from dry eye disease and aims to see if the new treatment can increase eye moisture or reduce inflammation.
Eligible Conditions
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 7, 14, 28 & 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7, 14, 28 & 90
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Unanesthetized Schirmer test
Secondary study objectives
Conjunctival Redness
Eye Dryness Score (EDS) - VAS
Ocular Discomfort Score (ODS) - VAS
+4 moreSide effects data
From 2021 Phase 2 trial • 369 Patients • NCT044981823%
Instillation site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle - Ocular
Vehicle - Nonocular
AR-15512 Ophthalmic Solution Higher Dose - Ocular
AR-15512 Ophthalmic Solution Higher Dose - Nonocular
AR-15512 Ophthalmic Solution Lower Dose - Nonocular
Pretreatment
AR-15512 Ophthalmic Solution Lower Dose - Ocular
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AR-15512 Ophthalmic Solution (0.003%)Experimental Treatment1 Intervention
0.003% AR-15512 to be administered BID for 90 days. Both eyes will be treated.
Group II: VehiclePlacebo Group1 Intervention
AR-15512 vehicle to be administered BID for 90 days. Both eyes will be treated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AR-15512 Ophthalmic Solution
2022
Completed Phase 3
~1120
Find a Location
Who is running the clinical trial?
Aerie PharmaceuticalsLead Sponsor
38 Previous Clinical Trials
7,859 Total Patients Enrolled
Michelle Senchyna, PhDStudy DirectorAerie Pharmaceuticals
3 Previous Clinical Trials
1,109 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used Tyrvaya™ (a medication that helps with quitting smoking) within the last 30 days or plan to use it during the study.You cannot use artificial tears within 2 hours before your screening visit or during the study.You have a history or currently have a serious disease that affects different parts of your body, such as your heart, lungs, liver, kidneys, blood, or immune system.You have dry eye symptoms based on a questionnaire and visual assessment.You have been using lid hygiene products within the past 14 days before the screening visit, or you plan to use them during the study.
Research Study Groups:
This trial has the following groups:- Group 1: AR-15512 Ophthalmic Solution (0.003%)
- Group 2: Vehicle
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Dry Eye Syndrome Patient Testimony for trial: Trial Name: NCT05360966 — Phase 3
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