Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2

Sponsor
ReGenTree, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT02974907
Collaborator
(none)
601
1
2
15.9
37.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
601 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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-2
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Sep 1, 2017
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: RGN-259

RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4

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
Other Names:
  • Tβ4
  • Thymosin Beta 4
  • Placebo Comparator: Placebo

    It is composed of the same excipients as RGN-259 but does not contain Tβ4

    Drug: Placebo
    It is composed of the same excipients as RGN-259 but does not contain Tβ4
    Other Names:
  • Vehicle Control
  • Outcome Measures

    Primary Outcome Measures

    1. Ocular Discomfort [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)

    2. Corneal Fluorescein Staining [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 Outcome Measures

    1. Corneal Fluorescein Staining [8, 15, 29 days after first dosing]

      Comparing each of active group & Placebo.

    2. Unanesthetized Schirmer's Test [29 days after first dosing]

      Comparing each of active group & Placebo.

    3. Ocular Surface Disease Index (OSDI)© [8, 15, 29 days after first dosing]

      Comparing each of active group & Placebo.

    4. Tear Film Break-Up Time [8, 15, 29 days after first dosing]

      Comparing each of active group & Placebo.

    Other Outcome Measures

    1. Visual Acuity [1, 8, 15, 29 days]

      Change or shifts from Baseline

    2. Change in Biomicroscopy Using the Slit-lamp [1, 8, 15, 29 days]

      Change or shifts from Baseline

    3. Adverse Event Query [1, 8, 15, 29 days]

      Frequencies

    4. Change in Biomicroscopy Using the Undilated Fundoscopy [1, 29 days]

      Change or shifts from Baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Andover, MA Andover Massachusetts United States 01810

    Sponsors and Collaborators

    • ReGenTree, LLC

    Investigators

    • Principal Investigator: Gail Torkildsen, MD, Ora Clinical Research and Development

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    ReGenTree, LLC
    ClinicalTrials.gov Identifier:
    NCT02974907
    Other Study ID Numbers:
    • RGN-259/16-110-0008
    First Posted:
    Nov 29, 2016
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by ReGenTree, LLC
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Subjects were screened during a 14-day study run-in period prior to randomization. And after run-in period and confirmation of inclusion and exclusion criteria, all eligible subjects were randomized in a 1:1 ratio to receive 0.1% RGN-259 or placebo ophthalmic solution bilaterally, four times per day (QID) for 28 days. The study comprised of 5 visits over the course of approximately 6 weeks.
    Pre-assignment Detail
    Arm/Group Title RGN-259 Placebo
    Arm/Group Description Active (0.1% RGN-259 ophthalmic solution) Placebo (Placebo ophthalmic solution)
    Period Title: Overall Study
    STARTED 299 302
    COMPLETED 286 292
    NOT COMPLETED 13 10

    Baseline Characteristics

    Arm/Group Title RGN-259 Placebo Total
    Arm/Group Description Active (0.1% RGN-259 ophthalmic solution) Placebo (Placebo ophthalmic solution) Total of all reporting groups
    Overall Participants 299 302 601
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    61.9
    (11.97)
    63.0
    (11.48)
    62.5
    (11.73)
    Sex: Female, Male (Count of Participants)
    Female
    215
    71.9%
    223
    73.8%
    438
    72.9%
    Male
    84
    28.1%
    79
    26.2%
    163
    27.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    23
    7.7%
    24
    7.9%
    47
    7.8%
    Not Hispanic or Latino
    275
    92%
    278
    92.1%
    553
    92%
    Unknown or Not Reported
    1
    0.3%
    0
    0%
    1
    0.2%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    2
    0.7%
    2
    0.3%
    Asian
    9
    3%
    10
    3.3%
    19
    3.2%
    Native Hawaiian or Other Pacific Islander
    1
    0.3%
    1
    0.3%
    2
    0.3%
    Black or African American
    36
    12%
    41
    13.6%
    77
    12.8%
    White
    251
    83.9%
    246
    81.5%
    497
    82.7%
    More than one race
    0
    0%
    1
    0.3%
    1
    0.2%
    Unknown or Not Reported
    2
    0.7%
    1
    0.3%
    3
    0.5%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RGN-259 Placebo
    Arm/Group Description Active (0.1% RGN-259 ophthalmic solution) Placebo (Placebo ophthalmic solution)
    Measure Participants 299 302
    Mean (95% Confidence Interval) [score on a scale]
    0.07
    -0.04
    2. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RGN-259 Placebo
    Arm/Group Description Active (0.1% RGN-259 ophthalmic solution) Placebo (Placebo ophthalmic solution)
    Measure Participants 111 107
    Mean (95% Confidence Interval) [score on a scale]
    0.07
    -0.01
    3. Secondary Outcome
    Title Corneal Fluorescein Staining
    Description Comparing each of active group & Placebo.
    Time Frame 8, 15, 29 days after first dosing

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    4. Secondary Outcome
    Title Unanesthetized Schirmer's Test
    Description Comparing each of active group & Placebo.
    Time Frame 29 days after first dosing

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    5. Secondary Outcome
    Title Ocular Surface Disease Index (OSDI)©
    Description Comparing each of active group & Placebo.
    Time Frame 8, 15, 29 days after first dosing

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    6. Secondary Outcome
    Title Tear Film Break-Up Time
    Description Comparing each of active group & Placebo.
    Time Frame 8, 15, 29 days after first dosing

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    7. Other Pre-specified Outcome
    Title Visual Acuity
    Description Change or shifts from Baseline
    Time Frame 1, 8, 15, 29 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    8. Other Pre-specified Outcome
    Title Change in Biomicroscopy Using the Slit-lamp
    Description Change or shifts from Baseline
    Time Frame 1, 8, 15, 29 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    9. Other Pre-specified Outcome
    Title Adverse Event Query
    Description Frequencies
    Time Frame 1, 8, 15, 29 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    10. Other Pre-specified Outcome
    Title Change in Biomicroscopy Using the Undilated Fundoscopy
    Description Change or shifts from Baseline
    Time Frame 1, 29 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame Adverse events were collected at every visit through study completion, up to Day 29.
    Adverse Event Reporting Description There was no anticipated/unanticipated deaths due to any cause in this study.
    Arm/Group Title RGN-259 Placebo
    Arm/Group Description Active (0.1% RGN-259 ophthalmic solution) Placebo (Placebo ophthalmic solution)
    All Cause Mortality
    RGN-259 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/299 (0%) 0/302 (0%)
    Serious Adverse Events
    RGN-259 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/299 (1%) 2/302 (0.7%)
    Ear and labyrinth disorders
    Vertigo 1/299 (0.3%) 1 0/302 (0%) 0
    Infections and infestations
    Diverticulitis 1/299 (0.3%) 1 0/302 (0%) 0
    Urinary Tract Infection 0/299 (0%) 0 1/302 (0.3%) 1
    Metabolism and nutrition disorders
    Hyperglycemia 1/299 (0.3%) 1 0/302 (0%) 0
    Nervous system disorders
    Transient Ischemic Attack 0/299 (0%) 0 1/302 (0.3%) 1
    Other (Not Including Serious) Adverse Events
    RGN-259 Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 19/299 (6.4%) 21/302 (7%)
    Eye disorders
    Visual Acuity Reduced 1/299 (0.3%) 1 10/302 (3.3%) 12
    Eye Pain 3/299 (1%) 3 1/302 (0.3%) 1
    Infections and infestations
    Nasopharyngitis 9/299 (3%) 9 6/302 (2%) 6
    Sinusitis 3/299 (1%) 3 3/302 (1%) 3
    Upper Respiratory Tract Infection 3/299 (1%) 3 1/302 (0.3%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Shinwook Kang
    Organization ReGenTree, LLC
    Phone 609-649-5505
    Email swkang@regentreellc.com
    Responsible Party:
    ReGenTree, LLC
    ClinicalTrials.gov Identifier:
    NCT02974907
    Other Study ID Numbers:
    • RGN-259/16-110-0008
    First Posted:
    Nov 29, 2016
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Nov 1, 2021