DRUG
RGN-259
A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
Status
Completed
Phase
Phase 3
Enrollment
601
Locations
1
Results
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 Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Full detailed description
Dry eye can be caused by many variable factors. Some examples include hormonal changes due to aging, or living in an environment of low humidity for long periods of time. Dry eye is a complex disease that may result in symptoms like discomfort, visual disturbance, and dryness. Patients with dry eye often have damage on the surface of the eye. In previous studies, RGN-259 has been shown to promote healing of the surface of the eye and decrease inflammation. It suggests that RGN-259 has a significant potential to be an important new safe and effective therapeutic in the treatment of dry eye syndrome.
Interventions
Treatment arms and agents.
DRUG
Placebo
It is composed of the same excipients as RGN-259 but does not contain Tβ4
Timeline
From registration to results.
First posted
Nov 29, 2016
Study start
Nov 2016
Primary completion
Sep 2017
Study completion
Mar 2018
Results posted
Jan 5, 2022
Registry updated
Jan 5, 2022
Outcomes
What the study measures.
Primary outcomes
Ocular Discomfort
Time frame · 29 days after first dosing
Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)
Corneal Fluorescein Staining
Time frame · 29 days after first dosing
Change from Baseline at Day 29 using the Ora Calibra® scale (5-point scale with half (0.5) increments where 0 = none and 4 = severe)
Secondary outcomes
Corneal Fluorescein Staining
Time frame · 8, 15, 29 days after first dosing
Comparing each of active group \& Placebo.
Unanesthetized Schirmer's Test
Time frame · 29 days after first dosing
Comparing each of active group \& Placebo.
Ocular Surface Disease Index (OSDI)©
Time frame · 8, 15, 29 days after first dosing
Comparing each of active group \& Placebo.
Tear Film Break-Up Time
Time frame · 8, 15, 29 days after first dosing
Comparing each of active group \& Placebo.
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 ab uncontrolled systemic disease:
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Andover, MA
Andover, Massachusetts, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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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.