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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye Syndrome

In brief

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.

Key facts

Study ID

NCT02974907

Run by

ReGenTree, LLC

People needed

601

Starts

2016-11-01

Expected to finish

2018-03-01

Last updated by the study team

2022-01-05

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 ab uncontrolled systemic disease:

Where it is running

• Andover, MA — Andover, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.