Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

Completed · Phase 2/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

NCT02597803

Run by

ReGenTree, LLC

People needed

317

Starts

2015-09-01

Expected to finish

2016-07-01

Last updated by the study team

2019-10-17

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
• Have a Schirmer's Test score of ≤10mm and ≥1mm
• Have a Tear Film Break-Up Time (TFBUT) ≤10 seconds
• Have a corneal fluorescein staining score of ≥2 in at least one region of the cornea

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 worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 6 months;
• Have an IOP > 25 mmHg at Visit 1;
• Have any planned ocular and/or lid surgeries over the study period;
• Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
• Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study);
• Have corrected visual acuity greater than or equal to logMAR +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1;

Where it is running

• Andover, MA — Andover, Massachusetts, United States

Full record on ClinicalTrials.gov

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