Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

Part of paid clinical trials in Andover, Massachusetts.

Sponsor
ReGenTree, LLC
Study ID
NCT02597803
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Dry Eye Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RGN-259 — DRUG
    A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days
  • Placebo — DRUG
    It is composed of the same excipients as RGN-259 but does not contain Tβ4

Study Details

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.

Key Dates

Start date
Sep 30, 2015
Status verified
Oct 2019
Primary completion
Jun 30, 2016
Completion
Jul 31, 2016

Study Design

Enrollment
317 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High Dose RGN-259
    High dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4
  • Placebo Comparator: Placebo
    It is composed of the same excipients as RGN-259 but does not contain Tβ4
  • Experimental: Low Dose RGN-259
    Low dose RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4

Primary Outcome Measure

Total corneal fluorescein staining score at day29 [ Time Frame: 29 days after first dosing ]

Locations (1)

FacilityCityStateZIPSite coordinators
Andover, MAAndoverMassachusetts01810-

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