Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye

NCT01393132 | Completed Phase 2 Results

• 1 other identifier: 1003008179
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing. The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May, 2010). The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface healing, may be able to promote healing of the corneal surface allowing for more conventional modalities to take over and maintain a smooth and regular ocular surface. The investigators hope to be able to demonstrate an improvement in visual acuity, surface healing and a reduction in dry-eye related symptoms.

Conditions

Dry Eye; Sjogren's Syndrome; Graft vs. Host Disease

Keywords

Dry Eye; Sjogren's Syndrome; Graft vs. Host Disease; Rheumatoid arthritis; Systemic lupus erythematosus; Scleroderma

Outcome Measures

Primary Outcomes (1)

• Safety

  Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits).

  Day 1, Day 14, Day 28 and Day 56

Secondary Outcomes (3)

• Corneal Fluorescein Staining

  Days 56 (+28 day follow up)

• Ocular Discomfort Index

  Days 56 (+28 day follow up)

• Tear Film Break up Time

  Days 56 (+28 day follow up)

Study Arms (2)

Thymosin Beta 4 eye drops

EXPERIMENTAL

It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, six times daily for 28 days

Drug: Thymosin Beta 4 eye drops

Vehicle Control

PLACEBO COMPARATOR

It is composed of the same excipients as RGN-259 but does not contain Tβ4 for direct instillation into each eye, six times daily for 28 days.

Drug: Vehicle Control

Interventions

Thymosin Beta 4 eye drops DRUG

Patients will be randomized and will receive the same eye drops the Thymosin Beta 4.

Also known as: Tβ4

Thymosin Beta 4 eye drops

Vehicle Control DRUG

Patients will be randomized and will receive the same eye drops without the Thymosin Beta 4.

Also known as: Vehicle

Vehicle Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Schirmers of \< 5 mm at 5 minutes
• TFBUT: less than 10 seconds
• Corneal staining of \>3 of 15: conjunctival staining of \>3 of 18
• Ocular Surface Disease Index of \> 50
• Presumed best corrected vision of 20/60 or better

You may not qualify if:

• Acute or inflammatory corneal disease
• Pregnancy or lactation
• Monocular status
• Punctal occlusion within 30 days
• Ocular surgery within 3 months
• Corneal thinning of \>50%
• Active corneal infection
• History of ocular malignancy
• Retinal neovascularization
• Current use of topical cyclosporin A

Sponsors & Collaborators

• Michigan Cornea Consultants, PC: lead
• Kresge Eye Institute: collaborator

Study Sites (1)

Michigan Cornea Consultants, P.C.

Southfield, Michigan, 48034, United States

Location

Related Publications (1)

• Sosne G, Dunn SP, Kim C. Thymosin beta4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial. Cornea. 2015 May;34(5):491-6. doi: 10.1097/ICO.0000000000000379.

  PMID: 25826322 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Sjogren's Syndrome; Graft vs Host Disease; Arthritis, Rheumatoid; Lupus Erythematosus, Systemic; Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Scleroderma, Systemic; Skin Diseases

Results Point of Contact

• Title: Gabriel Sosne, MD
• Organization: Wayne State Univeristy, Detroit, MI

gsosne@med.wayne.edu

248-594-6702

Study Officials

• Steven P Dunn, M.D.

  Michigan Cornea Consultants, P.C.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 13, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 23, 2015
• Results First Posted: December 23, 2015

Record last verified: 2015-12

Locations

US (1)