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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03937882
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : July 7, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Dry Eye Drug: RGN-259 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized in a 1:1 ratio RGN-259 to placebo ophthalmic solution.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All subjects, investigators, and study personnel involved with the conduct of the study will be masked with regard to treatment assignments.
Primary Purpose: Treatment
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-3)
Actual Study Start Date : May 24, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: RGN-259
RGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4
Drug: RGN-259
A preservative-free, sterile eye drop solution containing Thymosin beta 4 for direct instillation into each eye, four times a day (QID) for 14 days
Other Names:
  • Tβ4
  • Thymosin Beta 4

Placebo Comparator: Placebo
It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
Drug: Placebo
It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
Other Name: Vehicle Control

Primary Outcome Measures :
  1. Corneal staining [ Time Frame: 15 days after first dosing ]
    Mean change from baseline to Day 15 of Inferior Corneal Fluorescein Staining

  2. Ocular Discomfort 6-point (0=none, 5=worst) scale [ Time Frame: 15 days after first dosing ]
    Mean change from baseline to Day 15 of Ocular Discomfort severity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03937882

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Contact: Shinwook Kang 609-649-5505

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United States, California
Eye Research Foundation Recruiting
Newport Beach, California, United States, 92663
Contact: Wirta L. David, MD         
United States, Colorado
Vision Institute Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Erik Anderson, MD         
United States, Indiana
Midwest Cornea Associates, LLC Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Blair Boehmer, MD         
United States, Kentucky
The Eye Care Institute Recruiting
Louisville, Kentucky, United States, 40206
Contact: Guruprasad R Pattar, MD., PhD.         
United States, Massachusetts
Andover Eye Associates Recruiting
Andover, Massachusetts, United States, 01810
Contact: Gail Torkildsen, MD         
Andover Eye Associates Recruiting
Raynham, Massachusetts, United States, 02767
Contact: Kenneth R. Kenyon, MD         
United States, Nevada
Center For Sight Recruiting
Henderson, Nevada, United States, 89052
Contact: Eva Liang, MD         
United States, North Carolina
Oculus Research, Inc. at the Eye Care Center Recruiting
Raleigh, North Carolina, United States, 27603
Contact: Carol Aune, OD         
Visual Eyes Optometric Recruiting
Shelby, North Carolina, United States, 28150
Contact: Nancy Cline, MD         
United States, Pennsylvania
Scott & Christie and Associates, PC Recruiting
Cranberry Township, Pennsylvania, United States, 16066
Contact: Daniel V. Zimmer, MD         
United States, Rhode Island
Andover Eyte Associates Recruiting
Warwick, Rhode Island, United States, 02886
Contact: Robert Jordan, OD         
United States, Tennessee
Total Eye Care, P.A. Recruiting
Memphis, Tennessee, United States, 38119
Contact: Eugene McLaurin, MD         
United States, Utah
Mountain View Eye Center Recruiting
Layton, Utah, United States, 84041
Contact: Jared Peterson, MD         
Country Hills Eye Center Recruiting
Ogden, Utah, United States, 84403
Contact: Jackson Lever, MD         
United States, Virginia
Piedmont Eye Center Recruiting
Lynchburg, Virginia, United States, 24502
Contact: James Paauw, MD         
Sponsors and Collaborators
ReGenTree, LLC
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Responsible Party: ReGenTree, LLC Identifier: NCT03937882    
Other Study ID Numbers: RGN-259/19-110-0002
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ReGenTree, LLC:
Dry Eye
Dry Eye Syndrome
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases