NCT02974907

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
601

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

January 5, 2022

Completed
Last Updated

January 5, 2022

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

November 23, 2016

Results QC Date

November 5, 2021

Last Update Submit

December 9, 2021

Conditions

Dry Eye Syndrome

Keywords

Dry Eye SyndromeDry EyeDES

Outcome Measures

Primary Outcomes (2)

  • Ocular Discomfort

    Change from Baseline at Day 29 using the Ora Calibra® Ocular Discomfort Scale (6-point scale where 0 = none and 5 = worst)

    29 days after first dosing

  • Corneal Fluorescein Staining

    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)

    29 days after first dosing

Secondary Outcomes (4)

  • Corneal Fluorescein Staining

    8, 15, 29 days after first dosing

  • Unanesthetized Schirmer's Test

    29 days after first dosing

  • Ocular Surface Disease Index (OSDI)©

    8, 15, 29 days after first dosing

  • Tear Film Break-Up Time

    8, 15, 29 days after first dosing

Other Outcomes (4)

  • Visual Acuity

    1, 8, 15, 29 days

  • Change in Biomicroscopy Using the Slit-lamp

    1, 8, 15, 29 days

  • Adverse Event Query

    1, 8, 15, 29 days

  • +1 more other outcomes

Study Arms (2)

RGN-259

EXPERIMENTAL

RGN-259: It is a preservative-free, sterile eye drop solution containing Tβ4

Drug: RGN-259

Placebo

PLACEBO COMPARATOR

It is composed of the same excipients as RGN-259 but does not contain Tβ4

Drug: Placebo

Interventions

RGN-259DRUG

A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 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 Tβ4

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 ab uncontrolled systemic disease:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andover, MA

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

thymosin beta(4)

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Shinwook Kang
Organization
ReGenTree, LLC
swkang@regentreellc.com
609-649-5505

Study Officials

  • Gail Torkildsen, MD

    Ora Clinical Research and Development

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 29, 2016

Study Start

November 1, 2016

Primary Completion

September 1, 2017

Study Completion

March 1, 2018

Last Updated

January 5, 2022

Results First Posted

January 5, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)