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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
Study Summary
This trial will test a new treatment for dry eye disease. It will last 90 days and involve 20 sites in the US.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Unanesthetized Schirmer test
Secondary outcome measures
Conjunctival Redness
Eye Dryness Score (EDS) - VAS
Ocular Discomfort Score (ODS) - VAS
+4 moreTrial 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
~470
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
HasAR-15512 Ophthalmic Solution received regulatory approval from the FDA?
"AR-15512 Ophthalmic Solution is in Phase 3 of clinical trials, meaning that there is both efficacy and safety data supporting its use. Our team rates the medication as a 3 on our safe scale."
Answered by AI
Are new participants still being accepted into this research study?
"Yes, the trial is still recruiting patients. The original posting date was July 18th, 2022 and there have been edits as recently as November 11th, 2022."
Answered by AI
How many people can enroll in this clinical trial?
"This trial requires 460 individuals who meet the specified inclusion criteria. The sponsor, Aerie Pharmaceuticals, will be carrying out the study at various locations - two of which are Andover Eye Associates - Raynham in Raynham, Tennessee and Blink Research Center in Memphis, Colorado."
Answered by AI
Who else is applying?
What state do they live in?
California
Florida
What site did they apply to?
Pankratz Eye Institute
Argus Research Center
NVision Clinical Research - Torrance
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
1
3+
Why did patients apply to this trial?
Tired of my eyes.
Producing producing water. To contribute to the research to help improve and or we remove Dry Eye suffering.
PatientReceived 1 prior treatment
I’ve tried various eye drops but, so far, none have provided relief for more than a couple of hours.
PatientReceived 2+ prior treatments
I've tried other drugs and they have had side effects such as burning or a funny lingering taste. I would like to try different ones.
PatientReceived no prior treatments
I had to stop wearing hard gas permiable contacts due to dry eyes. My original pair of hard gas permiable contacts had custom holes drilled in them so tears could flow through holes to help contacts float and not stick to my eyes. I have had dry eyes for several years. I have tried eye drops (without much success) which had to be reapplied every one to two hours throughout the day.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
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