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

Part of paid clinical trials in Andover, Massachusetts.

Sponsor
ReGenTree, LLC
Study ID
NCT02974907
Phase
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
Nov 30, 2016
Status verified
Nov 2021
Primary completion
Sep 30, 2017
Completion
Mar 31, 2018

Study Design

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

Arms

  • Experimental: RGN-259
    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

Primary Outcome Measure

Ocular Discomfort [ Time Frame: 29 days after first dosing ]

Locations (1)

FacilityCityStateZIPSite coordinators
Andover, MAAndoverMassachusetts01810-

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