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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye Syndromes, Dry Eye

In brief

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.

Key facts

Study ID

NCT03937882

Run by

ReGenTree, LLC

People needed

700

Starts

2019-05-24

Expected to finish

2021-10-07

Last updated by the study team

2022-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Oculus Research, Inc. at the Eye Care Center — Raleigh, North Carolina, United States
• Visual Eyes Optometric — Shelby, North Carolina, United States
• Bergstrom Eye Research, LLC — Fargo, North Dakota, United States
• Scott & Christie and Associates, PC — Cranberry Township, Pennsylvania, United States
• Andover Eye Associates — Warwick, Rhode Island, United States
• Total Eye Care, P.A. — Memphis, Tennessee, United States
• Texan Eye/Keystone Research — Austin, Texas, United States
• Mountain View Eye Center — Layton, Utah, United States
• Country Hills Eye Center — Ogden, Utah, United States
• Piedmont Eye Center — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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