Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Michigan Cornea Consultants, PC.
Recruitment status was  Recruiting
Kresge Eye Institute
Information provided by:
Michigan Cornea Consultants, PC Identifier:
First received: July 7, 2011
Last updated: July 11, 2012
Last verified: July 2011

July 7, 2011
July 11, 2012
March 2011
December 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01393132 on Archive Site
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.
Same as current
Not Provided
Not Provided
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
Comparative Study of Thymosin Beta 4 Eye Drops or Vehicle in the Treatment of Patients With Ocular Surface Defects Due to Severe Dry Eye

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.

See above

Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Dry Eye
  • Sjogren's Syndrome
  • Graft vs. Host Disease
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
December 2012   (final data collection date for primary outcome measure)

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
18 Years and older
Contact: Tina Macleod 248-350-1130
Contact: Steven P Dunn 248-350-1130
United States
Steven P. Dunn, M.D., Michigan Cornea Consultants, P.C.
Michigan Cornea Consultants, PC
Kresge Eye Institute
Principal Investigator: Steven P Dunn, M.D. Michigan Cornea Consultants, P.C.
Michigan Cornea Consultants, PC
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP