NCT02597803

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
317

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2

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

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

9 months

First QC Date

October 26, 2015

Last Update Submit

October 7, 2019

Conditions

Dry Eye Syndrome

Keywords

Dry Eye SyndromeDry EyeDES

Outcome Measures

Primary Outcomes (2)

  • Total corneal fluorescein staining score at day29

    29 days after first dosing

  • Total ocular discomfort score at day29

    29 days after first dosing

Secondary Outcomes (3)

  • Tear film break-up time at day 8, 15, 29

    8, 15, 29 days after first dosing

  • Unanesthetized Schirmer's Test at day 8, 15, 29

    8, 15, 29 days after first dosing

  • Ocular Surface Disease Index (OSDI)© at day 8, 15, 29

    8, 15, 29 days after first dosing

Other Outcomes (6)

  • Visual acuity ( ETDRS, Early Treatment Diabetic Retinopathy Study scale) at 1, 8, 15, 29 days after first dosing

    1, 8, 15, 29 days after first dosing

  • Change in biomicroscopy using slit-lamp at 8, 15, 29 days after first dosing

    1, 8, 15, 29 days after first dosing

  • Corneal Sensitivity (aesthesiometer (Cochet-Bonnet at 1, 8, 15, 29 days after first dosing

    1, 8, 15, 29 days after first dosing

  • +3 more other outcomes

Study Arms (3)

High Dose RGN-259

EXPERIMENTAL

High dose 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

Low Dose RGN-259

EXPERIMENTAL

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

Drug: RGN-259

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
High Dose RGN-259Low Dose 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
  • Have a Schirmer's Test score of ≤10mm and ≥1mm
  • Have a Tear Film Break-Up Time (TFBUT) ≤10 seconds
  • Have a corneal fluorescein staining score of ≥2 in at least one region of the cornea

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 worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
  • Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 6 months;
  • Have an IOP \> 25 mmHg at Visit 1;
  • Have any planned ocular and/or lid surgeries over the study period;
  • Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
  • Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study);
  • Have corrected visual acuity greater than or equal to logMAR +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1;

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

Study Officials

  • Gail Torkildsen, MD

    Ora Clinical Research and Development

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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

October 26, 2015

First Posted

November 5, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

October 17, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)