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
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
Status
Completed
Phase
Phase 3
Enrollment
700
Locations
20
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
Timeline
From registration to results.
First posted
May 6, 2019
Study start
May 24, 2019
Primary completion
Nov 8, 2020
Study completion
Oct 7, 2021
Results posted
Not reported
Registry updated
May 9, 2022
Outcomes
What the study measures.
Primary outcomes
Corneal staining
Time frame · 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
Time frame · 15 days after first dosing
Mean change from baseline to Day 15 of Ocular Discomfort severity
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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
Study locations
20 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States
Eye Research Foundation
Newport Beach, California, United States
Vision Institute
Colorado Springs, Colorado, United States
Dovilan Wyatt MD, LLC
Chicago, Illinois, United States
Whitson Vision
Indianapolis, Indiana, United States
Midwest Cornea Associates, LLC
Indianapolis, Indiana, United States
The Eye Care Institute
Louisville, Kentucky, United States
Andover Eye Associates
Andover, Massachusetts, United States
Andover Eye Associates
Raynham, Massachusetts, United States
Center For Sight
Henderson, Nevada, United States
Oculus Research, Inc. at the Eye Care Center
Raleigh, North Carolina, 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
Andover Eye Associates
Warwick, Rhode Island, United States
Total Eye Care, P.A.
Memphis, Tennessee, United States
Texan Eye/Keystone Research
Austin, Texas, United States
Mountain View Eye Center
Layton, Utah, United States
Country Hills Eye Center
Ogden, Utah, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Thymosin Beta-4.
NCT IDStudyPhase / statusEnrollmentUpdated
Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction
Beijing Northland Biotech. Co., Ltd. · Acute Myocardial Infarction (AMI) · Acute Myocardial Infarction of Anterior Wall
Phase 2
Not yet recruiting
189
2026-05
TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD
Hudson Biotech · Atherosclerotic Cardiovascular Diseases · Endothelial Dysfunction
Phase 1 / Phase 2
Recruiting
80
2026-03
Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
ReGenTree, LLC · Neurotrophic Keratopathy
Phase 3
Recruiting
70
2025-12
Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction
Beijing Northland Biotech. Co., Ltd. · Acute Myocardial Infarction
Phase 2
Completed
90
2024-06
Safety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.Infarction
Beijing Northland Biotech. Co., Ltd. · Acute Myocardial Infarction
Phase 2
Completed
62
2022-08
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
ReGenTree, LLC · Dry Eye Syndrome
Phase 3
Completed
601
2022-01
A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction
RegeneRx Biopharmaceuticals, Inc. · Acute Myocardial Infarction · ST Elevation Myocardial Infarction
Phase 2
Withdrawn
0
2021-09
A Phase 1a Study of Thymosin Beta 4 in Healthy Volunteers
Beijing Northland Biotech. Co., Ltd. · Healthy
Phase 1
Completed
54
2020-09
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.