Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
ReGenTree, LLC
Study ID
NCT03937882
Phase
PHASE3
Status
Completed

Conditions

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 Thymosin beta 4 for direct instillation into each eye, four times a day (QID) for 14 days
  • Placebo — DRUG
    It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4

Study Details

The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Key Dates

Start date
May 24, 2019
Status verified
Nov 2021
Primary completion
Nov 8, 2020
Completion
Oct 7, 2021

Study Design

Enrollment
700 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 Thymosin beta 4
  • Placebo Comparator: Placebo
    It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4

Primary Outcome Measure

Corneal staining [ Time Frame: 15 days after first dosing ]

Locations (20)

FacilityCityStateZIPSite coordinators
Cornea and Cataract Consultants of ArizonaPhoenixArizona85032-
Eye Research FoundationNewport BeachCalifornia92663-
Vision InstituteColorado SpringsColorado80907-
Dovilan Wyatt MD, LLCChicagoIllinois60619-
Midwest Cornea Associates, LLCIndianapolisIndiana46290-
Whitson VisionIndianapolisIndiana46240-
The Eye Care InstituteLouisvilleKentucky40206-
Andover Eye AssociatesAndoverMassachusetts01810-
Andover Eye AssociatesRaynhamMassachusetts02767-
Center For SightHendersonNevada89052-
Oculus Research, Inc. at the Eye Care CenterRaleighNorth Carolina27603-
Visual Eyes OptometricShelbyNorth Carolina28150-
Bergstrom Eye Research, LLCFargoNorth Dakota58103-
Scott & Christie and Associates, PCCranberry TownshipPennsylvania16066-
Andover Eye AssociatesWarwickRhode Island02886-
Total Eye Care, P.A.MemphisTennessee38119-
Texan Eye/Keystone ResearchAustinTexas78731-
Mountain View Eye CenterLaytonUtah84041-
Country Hills Eye CenterOgdenUtah84403-
Piedmont Eye CenterLynchburgVirginia24502-

Find similar trials in Phoenix, AZ

By research site
Cornea and Cataract Consultants of Arizona· Phoenix, AZEye Research Foundation· Newport Beach, CAVision Institute· Colorado Springs, CODovilan Wyatt MD, LLC· Chicago, ILMidwest Cornea Associates, LLC· Indianapolis, INWhitson Vision· Indianapolis, IN

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