Back to resultsAssessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
RGN-259
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye Syndrome, Dry Eye, DES
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 ab uncontrolled systemic disease:
Sites / Locations
- Andover, MA
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 Tβ4
It is composed of the same excipients as RGN-259 but does not contain Tβ4
Outcomes
Primary Outcome Measures
Ocular Discomfort
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
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 Outcome Measures
Corneal Fluorescein Staining
Comparing each of active group & Placebo.
Unanesthetized Schirmer's Test
Comparing each of active group & Placebo.
Ocular Surface Disease Index (OSDI)©
Comparing each of active group & Placebo.
Tear Film Break-Up Time
Comparing each of active group & Placebo.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02974907
Brief Title
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
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-2
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ReGenTree, LLC
4. Oversight
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 Solutions to placebo for the treatment of the signs and symptoms of dry eye.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Dry Eye Syndrome, Dry Eye, DES
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
601 (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 Tβ4
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
It is composed of the same excipients as RGN-259 but does not contain Tβ4
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 Tβ4 for direct instillation into each eye, four times a day (QID) for 28 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 Tβ4
Primary Outcome Measure Information:
Title
Ocular Discomfort
Description
Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)
Time Frame
29 days after first dosing
Title
Corneal Fluorescein Staining
Description
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)
Time Frame
29 days after first dosing
Secondary Outcome Measure Information:
Title
Corneal Fluorescein Staining
Description
Comparing each of active group & Placebo.
Time Frame
8, 15, 29 days after first dosing
Title
Unanesthetized Schirmer's Test
Description
Comparing each of active group & Placebo.
Time Frame
29 days after first dosing
Title
Ocular Surface Disease Index (OSDI)©
Description
Comparing each of active group & Placebo.
Time Frame
8, 15, 29 days after first dosing
Title
Tear Film Break-Up Time
Description
Comparing each of active group & Placebo.
Time Frame
8, 15, 29 days after first dosing
Other Pre-specified Outcome Measures:
Title
Visual Acuity
Description
Change or shifts from Baseline
Time Frame
1, 8, 15, 29 days
Title
Change in Biomicroscopy Using the Slit-lamp
Description
Change or shifts from Baseline
Time Frame
1, 8, 15, 29 days
Title
Adverse Event Query
Description
Frequencies
Time Frame
1, 8, 15, 29 days
Title
Change in Biomicroscopy Using the Undilated Fundoscopy
Description
Change or shifts from Baseline
Time Frame
1, 29 days
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 ab uncontrolled systemic disease:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Torkildsen, MD
Organizational Affiliation
Ora Clinical Research and Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andover, MA
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
We'll reach out to this number within 24 hrs