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

Primary Purpose

Dry Eye Syndromes, Dry Eye

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
RGN-259
Placebo
Sponsored by
ReGenTree, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Dry Eye, Dry Eye Syndrome, DES

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cornea and Cataract Consultants of Arizona
  • Eye Research Foundation
  • Vision Institute
  • Dovilan Wyatt MD, LLC
  • Whitson Vision
  • Midwest Cornea Associates, LLC
  • The Eye Care Institute
  • Andover Eye Associates
  • Andover Eye Associates
  • Center For Sight
  • Oculus Research, Inc. at the Eye Care Center
  • Visual Eyes Optometric
  • Bergstrom Eye Research, LLC
  • Scott & Christie and Associates, PC
  • Andover Eye Associates
  • Total Eye Care, P.A.
  • Texan Eye/Keystone Research
  • Mountain View Eye Center
  • Country Hills Eye Center
  • Piedmont Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RGN-259

Placebo

Arm Description

RGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4

It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4

Outcomes

Primary Outcome Measures

Corneal staining
Mean change from baseline to Day 15 of Inferior Corneal Fluorescein Staining
Ocular Discomfort 6-point (0=none, 5=worst) scale
Mean change from baseline to Day 15 of Ocular Discomfort severity

Secondary Outcome Measures

Full Information

First Posted
May 1, 2019
Last Updated
May 2, 2022
Sponsor
ReGenTree, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03937882
Brief Title
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
Acronym
ARISE-3
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 24, 2019 (Actual)
Primary Completion Date
November 8, 2020 (Actual)
Study Completion Date
October 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ReGenTree, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Dry Eye
Keywords
Dry Eye, Dry Eye Syndrome, DES

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized in a 1:1 ratio RGN-259 to placebo ophthalmic solution.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All subjects, investigators, and study personnel involved with the conduct of the study will be masked with regard to treatment assignments.
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RGN-259
Arm Type
Experimental
Arm Description
RGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
Intervention Type
Drug
Intervention Name(s)
RGN-259
Other Intervention Name(s)
Tβ4, Thymosin Beta 4
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle Control
Intervention Description
It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
Primary Outcome Measure Information:
Title
Corneal staining
Description
Mean change from baseline to Day 15 of Inferior Corneal Fluorescein Staining
Time Frame
15 days after first dosing
Title
Ocular Discomfort 6-point (0=none, 5=worst) scale
Description
Mean change from baseline to Day 15 of Ocular Discomfort severity
Time Frame
15 days after first dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cornea and Cataract Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Vision Institute
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Dovilan Wyatt MD, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60619
Country
United States
Facility Name
Whitson Vision
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
Midwest Cornea Associates, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
The Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Andover Eye Associates
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States
Facility Name
Center For Sight
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Oculus Research, Inc. at the Eye Care Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
Visual Eyes Optometric
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Bergstrom Eye Research, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Andover Eye Associates
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Total Eye Care, P.A.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Texan Eye/Keystone Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Mountain View Eye Center
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Country Hills Eye Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Piedmont Eye Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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