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COMPLETED
NCT02974907
PHASE3

Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2

Sponsor: ReGenTree, LLC

View on ClinicalTrials.gov

Summary

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

Official title: 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-2

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

601

Start Date

2016-11

Completion Date

2018-03

Last Updated

2026-10-21

Healthy Volunteers

No

Interventions

DRUG

RGN-259

A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days

DRUG

Placebo

It is composed of the same excipients as RGN-259 but does not contain Tβ4

Locations (10)

Cornea & Cataract Consultants of Arizona

Phoenix, Arizona, United States

Eye Research Foundation

Newport Beach, California, United States

Vision Institute

Colorado Springs, Colorado, United States

The Eye Care Group

Waterbury, Connecticut, United States

Midwest Cornea Associates, LLC

Indianapolis, Indiana, United States

Eye Care Institute

Louisville, Kentucky, United States

Andover Eye Associates

Andover, Massachusetts, United States

Total Eye Care, P.A.

Memphis, Tennessee, United States

Nashville Vision Associates

Nashville, Tennessee, United States

Eye Consultants of Texas

Grapevine, Texas, United States