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

This study has been completed.
Sponsor:
Collaborator:
Kresge Eye Institute
Information provided by (Responsible Party):
Steven P. Dunn, M.D., Michigan Cornea Consultants, PC
ClinicalTrials.gov Identifier:
NCT01393132
First received: July 7, 2011
Last updated: April 7, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Dry Eye
Sjogren's Syndrome
Graft vs. Host Disease
Drug: Thymosin Beta 4 eye drops vs. vehicle
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Study of Thymosin Beta 4 Eye Drops or Vehicle in the Treatment of Patients With Ocular Surface Defects Due to Severe Dry Eye

Resource links provided by NLM:


Further study details as provided by Michigan Cornea Consultants, PC:

Primary Outcome Measures:
  • Corneal and Conjunctival Staining - Change from baseline [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The corneal and conjunctival surface will be monitored during treatment and for a 30 day period afterwards for improvement of surface staining (using a standardized grading system) and corresponding visual acuity (Snellen) and symptomatic improvement using the validated Ocular Surface Disease Index (OSDI).


Secondary Outcome Measures:
  • Snellen visual acuity - Change from baseline [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Snellen visual acuity will be measured using standardized eye charts and lighting conditions.


Enrollment: 18
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Thymosin vs. Placebo
Comparison
Drug: Thymosin Beta 4 eye drops vs. vehicle
Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4.

Detailed Description:

See above

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393132

Locations
United States, Michigan
Michigan Cornea Consultants, P.C.
Southfield, Michigan, United States, 48034
Sponsors and Collaborators
Michigan Cornea Consultants, PC
Kresge Eye Institute
Investigators
Principal Investigator: Steven P Dunn, M.D. Michigan Cornea Consultants, P.C.
  More Information

No publications provided

Responsible Party: Steven P. Dunn, M.D., Principal Investigator, Michigan Cornea Consultants, PC
ClinicalTrials.gov Identifier: NCT01393132     History of Changes
Other Study ID Numbers: 1003008179
Study First Received: July 7, 2011
Last Updated: April 7, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Michigan Cornea Consultants, PC:
Dry Eye
Sjogren's Syndrome
Graft vs. Host Disease
Rheumatoid arthritis
Systemic lupus erythematosus
Scleroderma

Additional relevant MeSH terms:
Dry Eye Syndromes
Graft vs Host Disease
Keratoconjunctivitis Sicca
Sjogren's Syndrome
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Conjunctival Diseases
Conjunctivitis
Connective Tissue Diseases
Corneal Diseases
Eye Diseases
Immune System Diseases
Joint Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Mouth Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Xerostomia
Ophthalmic Solutions
Tetrahydrozoline
Autonomic Agents
Cardiovascular Agents
Nasal Decongestants
Peripheral Nervous System Agents
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on April 19, 2015