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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 9
Healthy volunteers: no

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

Arms:
arm 1: It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, six times daily for 28 days arm 2: It is composed of the same excipients as RGN-259 but does not contain Tβ4 for direct instillation into each eye, six times daily for 28 days.

Interventions: intervention 1: Thymosin Beta 4 eye drops intervention 2: Vehicle Control
Intervention descriptions: intervention 1: Patients will be randomized and will receive the same eye drops the Thymosin Beta 4. intervention 2: Patients will be randomized and will receive the same eye drops without the Thymosin Beta 4.

Protocol document: