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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT02974907 (opens ClinicalTrials.gov in a new tab)Other idRGN-259/16-110-0008
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
601 participants (actual)
Sponsor
ReGenTree, LLC · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Nov 2016
Primary completion
Sept 2017
Completion
Mar 2018
First posted
29 Nov 2016 (estimated)
Last update posted
5 Jan 2022
Conditions
Dry Eye Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. Ph 3

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

    NCT02974907

    Nov 2016 to Mar 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • RGN-259Drug
  • PlaceboDrug

Arms2

  • 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 outcomes2

Outcomes the sponsor listed as primary.

  1. Ocular Discomfort

    Time frame · 29 days after first dosing

    Registry description

    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

    Time frame · 29 days after first dosing

    Registry 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)

Secondary outcomes(4)

  1. Corneal Fluorescein Staining

    Time frame · 8, 15, 29 days after first dosing

    Registry description

    Comparing each of active group \& Placebo.

  2. Unanesthetized Schirmer's Test

    Time frame · 29 days after first dosing

    Registry description

    Comparing each of active group \& Placebo.

  3. Ocular Surface Disease Index (OSDI)©

    Time frame · 8, 15, 29 days after first dosing

    Registry description

    Comparing each of active group \& Placebo.

  4. Tear Film Break-Up Time

    Time frame · 8, 15, 29 days after first dosing

    Registry description

    Comparing each of active group \& Placebo.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 29 days after first dosing

Ocular Discomfort

GroupValue (score on a scale)
RGN-2590.07
Placebo-0.04
Primary outcomeMean· 29 days after first dosing

Corneal Fluorescein Staining

GroupValue (score on a scale)
RGN-2590.07
Placebo-0.01
Secondary and other outcome results(6)
Secondary outcome· 8, 15, 29 days after first dosing

Corneal Fluorescein Staining

GroupValue
Secondary outcome· 29 days after first dosing

Unanesthetized Schirmer's Test

GroupValue
Secondary outcome· 8, 15, 29 days after first dosing

Ocular Surface Disease Index (OSDI)©

GroupValue
Secondary outcome· 8, 15, 29 days after first dosing

Tear Film Break-Up Time

GroupValue
Other pre specified outcome· 1, 8, 15, 29 days

Visual Acuity

GroupValue
Other pre specified outcome· 1, 8, 15, 29 days

Change in Biomicroscopy Using the Slit-lamp

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
RGN-259Active (0.1% RGN-259 ophthalmic solution)0 / 2993 / 29919 / 299
PlaceboPlacebo (Placebo ophthalmic solution)0 / 3022 / 30221 / 302

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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:

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