Phase 2
Completed N=9
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
Dry Eye Disease · Sjogren's Syndrome · Graft vs. Host Disease
Source: ClinicalTrials.gov NCT01393132 ↗
Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Safety — 0; 0 event
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety |
0; 0 | — |
| SECONDARY Corneal Fluorescein Staining |
4.5; 11.0 | 0.0108 sig |
| SECONDARY Ocular Discomfort Index |
45.625; 67.233 | 0.0141 sig |
| SECONDARY Tear Film Break up Time |
5.550; 2.848 | 0.0162 sig |
Eligibility Criteria
Inclusion Criteria
- Schirmers 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
Data sourced from ClinicalTrials.gov (NCT01393132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.