Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Hematology, Rheumatology |
| Therapuetic Areas: | Hematology, Ophthalmology, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | March 2011 |
| End Date: | December 2012 |
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.
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
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
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