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Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

Primary Purpose

Dry Eye Syndrome

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

RGN-259

Placebo

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye Syndrome, Dry Eye, DES

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
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

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 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;

Sites / Locations

Andover, MA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

High Dose RGN-259

Placebo

Low Dose RGN-259

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Total corneal fluorescein staining score at day29

Total ocular discomfort score at day29

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT02597803

First Posted

October 26, 2015

Last Updated

October 7, 2019

Sponsor

ReGenTree, LLC

1. Study Identification

Unique Protocol Identification Number

NCT02597803

Brief Title

Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

Official Title

A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of RGN-259 Ophthalmic Solutions for the Treatment of Dry Eye: ARISE-1

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ReGenTree, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Dry eye can be caused by many variable factors. Some examples include hormonal changes due to aging, or living in an environment of low humidity for long periods of time. Dry eye is a complex disease that may result in symptoms like discomfort, visual disturbance, and dryness. Patients with dry eye often have damage on the surface of the eye. In previous studies, RGN-259 has been shown to promote healing of the surface of the eye and decrease inflammation. It suggests that RGN-259 has a significant potential to be an important new safe and effective therapeutic in the treatment of dry eye syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndrome

Keywords

Dry Eye Syndrome, Dry Eye, DES

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

317 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High Dose RGN-259

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Low Dose RGN-259

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

RGN-259

Other Intervention Name(s)

Tβ4, Thymosin Beta 4

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Vehicle Control

Intervention Description

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

Primary Outcome Measure Information:

Title

Total corneal fluorescein staining score at day29

Time Frame

29 days after first dosing

Title

Total ocular discomfort score at day29

Time Frame

29 days after first dosing

Secondary Outcome Measure Information:

Title

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

Time Frame

8, 15, 29 days after first dosing

Title

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

Time Frame

8, 15, 29 days after first dosing

Title

Time Frame

8, 15, 29 days after first dosing

Other Pre-specified Outcome Measures:

Title

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

Time Frame

1, 8, 15, 29 days after first dosing

Title

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

Time Frame

1, 8, 15, 29 days after first dosing

Title

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

Time Frame

1, 8, 15, 29 days after first dosing

Title

Adverse event query at Visits 1,2,3, 4 and 5

Time Frame

1, 8, 15, 29 days after first dosing

Title

Change in biomicroscopy using Undilated Fundoscopy at 1, 29 days after first dosing

Time Frame

1, 29 days after first dosing

Title

Intraocular Pressure at Visits 1, 29 days after first dosing

Time Frame

1, 29 days after first dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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 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 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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gail Torkildsen, MD

Organizational Affiliation

Ora Clinical Research and Development

Official's Role

Principal Investigator

Facility Information:

Facility Name

Andover, MA

City

Andover

State/Province

Massachusetts

ZIP/Postal Code

01810

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1

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