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

Michigan Cornea Consultants, PC

Status and phase: Completed; Phase 2

Conditions: Sjogren's Syndrome; Dry Eye; Graft vs. Host Disease

Treatments: Drug: Vehicle Control; Drug: Thymosin Beta 4 eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT01393132

1003008179

Details and patient eligibility

About

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.

Full description

See above

Enrollment: 9 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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9 participants in 2 patient groups, including a placebo group

Thymosin Beta 4 eye drops

Experimental group

Description:

It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, six times daily for 28 days

Treatment:

Drug: Thymosin Beta 4 eye drops

Vehicle Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: Vehicle Control