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

Phase 3

Completed

• Conditions: Dry Eye Syndromes; Dry Eye
• Interventions: Drug: Placebo; Drug: RGN-259

• Registration Number: NCT03937882
• Lead Sponsor: ReGenTree, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Study Start: 2019-05-24
• Primary Completion: 2020-11-08
• Study Completion: 2021-10-07
• Status Verified: 2021-11
• Disposition First Submitted: 2021-11-01
• Disposition First Submitted QC: 2021-11-01
• Disposition First Posted: 2021-11-03
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
RGN-259	RGN-259	RGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4

Primary Outcome Measures

Name	Time	Method
Corneal staining	15 days after first dosing	Mean change from baseline to Day 15 of Inferior Corneal Fluorescein Staining
Ocular Discomfort 6-point (0=none, 5=worst) scale	15 days after first dosing	Mean change from baseline to Day 15 of Ocular Discomfort severity

Trial Locations

Locations (18)

Oculus Research, Inc. at the Eye Care Center; 🇺🇸 Raleigh, North Carolina, United States

Center For Sight; 🇺🇸 Henderson, Nevada, United States

Dovilan Wyatt MD, LLC; 🇺🇸 Chicago, Illinois, United States

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

Vision Institute; 🇺🇸 Colorado Springs, Colorado, United States

Andover Eye Associates; 🇺🇸 Warwick, Rhode Island, 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

Total Eye Care, P.A.; 🇺🇸 Memphis, Tennessee, United States

Country Hills Eye Center; 🇺🇸 Ogden, Utah, United States

Mountain View Eye Center; 🇺🇸 Layton, Utah, United States

Piedmont Eye Center; 🇺🇸 Lynchburg, Virginia, United States

Cornea and Cataract Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

Midwest Cornea Associates, LLC; 🇺🇸 Indianapolis, Indiana, United States

Whitson Vision; 🇺🇸 Indianapolis, Indiana, United States

The Eye Care Institute; 🇺🇸 Louisville, Kentucky, United States

Texan Eye/Keystone Research; 🇺🇸 Austin, Texas, United States