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

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)

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Dry Eye Syndromes
• Intervention / Treatment: Drug: RGN-259; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 700
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Cornea and Cataract Consultants of Arizona
  • California
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Vision Institute
  • Illinois
    • Chicago, Illinois, United States, 60619
      • Dovilan Wyatt MD, LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46240
      • Whitson Vision
    • Indianapolis, Indiana, United States, 46290
      • Midwest Cornea Associates, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • The Eye Care Institute
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
    • Raynham, Massachusetts, United States, 02767
      • Andover Eye Associates
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Center for Sight
  • North Carolina
    • Raleigh, North Carolina, United States, 27603
      • Oculus Research, Inc. at the Eye Care Center
    • Shelby, North Carolina, United States, 28150
      • Visual Eyes Optometric
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Bergstrom Eye Research, LLC
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates, PC
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Andover Eye Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, P.A.
  • Texas
    • Austin, Texas, United States, 78731
      • Texan Eye/Keystone Research
  • Utah
    • Layton, Utah, United States, 84041
      • Mountain View Eye Center
    • Ogden, Utah, United States, 84403
      • Country Hills Eye Center
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Vehicle Control

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ReGenTree, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2019
• Primary Completion (Actual): November 8, 2020
• Study Completion (Actual): October 7, 2021

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Dry Eye; Dry Eye Syndrome; DES
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: RGN-259/19-110-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No