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

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ClinicalTrials.gov Identifier: NCT02974907
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
ReGenTree, LLC

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
Dry Eye Syndrome Drug: RGN-259 Drug: Placebo 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 Type : Interventional  (Clinical Trial)
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 : November 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : March 2018

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 Name: Vehicle Control




Primary Outcome Measures :
  1. Ocular discomfort [ Time Frame: 29 days after first dosing ]
    Change from Baseline to day 29

  2. Corneal Fluorescein staining [ Time Frame: 29 days after first dosing ]
    Change from Baseline to day 29


Secondary Outcome Measures :
  1. Corneal Fluorescein staining [ Time Frame: 8, 15, 29 days after first dosing ]
    Comparing each of active group & Placebo.

  2. Unanesthetized Schirmer's Test [ Time Frame: 29 days after first dosing ]
    Comparing each of active group & Placebo.

  3. Ocular Surface Disease Index (OSDI)© [ Time Frame: 8, 15, 29 days after first dosing ]
    Comparing each of active group & Placebo.

  4. Tear Film Break-Up Time [ Time Frame: 8, 15, 29 days after first dosing ]
    Comparing each of active group & Placebo.


Other Outcome Measures:
  1. Visual acuity [ Time Frame: 1, 8, 15, 29 days ]
    Change or shifts from Baseline

  2. Change in biomicroscopy using the slit-lamp [ Time Frame: 1, 8, 15, 29 days ]
    Change or shifts from Baseline

  3. Adverse event query [ Time Frame: 1, 8, 15, 29 days ]
    Frequencies

  4. Change in biomicroscopy using the Undilated Fundoscopy [ Time Frame: 1, 29 days ]
    Change or shifts from Baseline



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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 ab uncontrolled systemic disease:

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): NCT02974907


Locations
United States, Massachusetts
Andover, MA
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
ReGenTree, LLC
Investigators
Principal Investigator: Gail Torkildsen, MD Ora Clinical Research and Development

Responsible Party: ReGenTree, LLC
ClinicalTrials.gov Identifier: NCT02974907     History of Changes
Other Study ID Numbers: RGN-259/16-110-0008
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by ReGenTree, LLC:
Dry Eye Syndrome
Dry Eye
DES

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions