NCT03937882

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2019

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

May 24, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2021

Completed
Last Updated

May 9, 2022

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

May 1, 2019

Last Update Submit

May 2, 2022

Conditions

Dry Eye SyndromesDry Eye

Keywords

Dry EyeDry Eye SyndromeDES

Outcome Measures

Primary Outcomes (2)

  • Corneal staining

    Mean change from baseline to Day 15 of Inferior Corneal Fluorescein Staining

    15 days after first dosing

  • Ocular Discomfort 6-point (0=none, 5=worst) scale

    Mean change from baseline to Day 15 of Ocular Discomfort severity

    15 days after first dosing

Study Arms (2)

RGN-259

EXPERIMENTAL

RGN-259: It is a preservative-free, sterile eye drop solution containing Thymosin beta 4

Drug: RGN-259

Placebo

PLACEBO COMPARATOR

It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4

Drug: Placebo

Interventions

RGN-259DRUG

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

Also known as: Tβ4, Thymosin Beta 4
RGN-259
PlaceboDRUG

It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4

Also known as: Vehicle Control
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 an uncontrolled systemic disease;
  • Be a woman who is pregnant, nursing or planning a pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, 85032, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Dovilan Wyatt MD, LLC

Chicago, Illinois, 60619, United States

Location

Whitson Vision

Indianapolis, Indiana, 46240, United States

Location

Midwest Cornea Associates, LLC

Indianapolis, Indiana, 46290, United States

Location

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Andover Eye Associates

Raynham, Massachusetts, 02767, United States

Location

Center For Sight

Henderson, Nevada, 89052, United States

Location

Oculus Research, Inc. at the Eye Care Center

Raleigh, North Carolina, 27603, United States

Location

Visual Eyes Optometric

Shelby, North Carolina, 28150, United States

Location

Bergstrom Eye Research, LLC

Fargo, North Dakota, 58103, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Andover Eye Associates

Warwick, Rhode Island, 02886, United States

Location

Total Eye Care, P.A.

Memphis, Tennessee, 38119, United States

Location

Texan Eye/Keystone Research

Austin, Texas, 78731, United States

Location

Mountain View Eye Center

Layton, Utah, 84041, United States

Location

Country Hills Eye Center

Ogden, Utah, 84403, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

thymosin beta(4)

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All subjects, investigators, and study personnel involved with the conduct of the study will be masked with regard to treatment assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects will be randomized in a 1:1 ratio RGN-259 to placebo ophthalmic solution.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2019

First Posted

May 6, 2019

Study Start

May 24, 2019

Primary Completion

November 8, 2020

Study Completion

October 7, 2021

Last Updated

May 9, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(20)