Clinical trial NCT01393132: Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Michigan Cornea Consultants, PC
Sponsor class: OTHER
Collaborators: name: Kresge Eye Institute
First posted: 2011-07-13
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: See above

Eligibility 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

Primary outcomes:
measure: Safety
timeFrame: Day 1, Day 14, Day 28 and Day 56
Secondary outcomes:
measure: Corneal Fluorescein Staining
timeFrame: Days 56 (+28 day follow up)
measure: Ocular Discomfort Index
timeFrame: Days 56 (+28 day follow up)
measure: Tear Film Break up Time
timeFrame: Days 56 (+28 day follow up)
Other outcomes:
Locations:
city: Southfield
country: United States
facility: Michigan Cornea Consultants, P.C.
state: Michigan
Study officials:
affiliation: Michigan Cornea Consultants, P.C.
name: Steven P Dunn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.