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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937882
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
ReGenTree, LLC

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : November 8, 2020
Actual Study Completion Date : October 7, 2021
Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Information from the National Library of Medicine

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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03937882


Locations
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Sponsors and Collaborators
ReGenTree, LLC
More Information
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Responsible Party: ReGenTree, LLC
ClinicalTrials.gov Identifier: NCT03937882    
Other Study ID Numbers: RGN-259/19-110-0002
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: November 2021
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
DES
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Syndrome
Disease
Pathologic Processes
Lacrimal Apparatus Diseases
 Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases