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Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3 | Clinical Trials | Clareo Health

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Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3

A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solutions for the Treatment of Dry Eye (ARISE-3)

NCT03937882•ReGenTree, LLC

View on ClinicalTrials.gov

Summary

The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Be at least 18 years of age;
•Provide written informed consent;
•Have a subject reported history of dry eye for at least 6 months;
•Have a history of use or desire to use eye drops for dry eye symptoms within 6 months

Exclusion Criteria

•Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
•Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
•Have an uncontrolled systemic disease;
•Be a woman who is pregnant, nursing or planning a pregnancy

Locations (20)

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, United States

Eye Research Foundation

Newport Beach, California, United States

Vision Institute

Colorado Springs, Colorado, United States

Dovilan Wyatt MD, LLC

Chicago, Illinois, United States

Whitson Vision

Indianapolis, Indiana, United States

Midwest Cornea Associates, LLC

Indianapolis, Indiana, United States

The Eye Care Institute

Louisville, Kentucky, United States

Andover Eye Associates

Andover, Massachusetts, United States

Andover Eye Associates

Raynham, Massachusetts, United States

Center For Sight

Henderson, Nevada, United States

Key Dates

Start Date

May 24, 2019

Primary Completion Date

November 8, 2020

Completion Date

October 7, 2021

Last Updated

May 9, 2022

Enrollment

700

ACTUAL participants

Conditions

Dry Eye SyndromesDry Eye

Interventions

RGN-259

DRUG

Placebo

DRUG

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

NCT07463950

Dry Eye Disease (DED)

View study

RECRUITING

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

NCT07363824

Dry Eye DiseaseIron

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3

Inclusion Criteria

Exclusion Criteria

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment of Dry Eye Disease

Autologous Serum Eye Drops in Dry Eye Syndrome

Assessment of CataClear, Tear Film Stability, Tear Volume, and Dry Eye Symptoms Using Stem Cells Fortified Eye Drops