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Gabriel Sosne, David Crockford, J J. Finkelstein, George W. Ousler, III; Single-Center Study Evaluating the Safety and Efficacy of 0.1% Tβ4 Ophthalmic Solution Compared to Vehicle on the Signs and Symptoms of Dry Eye in the Controlled Adverse Environment (CAE) Model. Invest. Ophthalmol. Vis. Sci. 2012;53(14):577.
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Thymosin Beta 4 (Tß4) is a synthetic copy of the naturally-occurring 43-amino acid peptide that is found in a variety of tissues and nucleated cell types. The purpose of this study was to evaluate the safety and efficacy of RGN-259 (0.1% Tß4 ophthalmic solution) compared to placebo (vehicle) on the signs and symptoms of dry eye in the Controlled Adverse Environment (CAE) model.
Sixty nine subjects completed a Phase II, randomized, double-masked, placebo-controlled single-center study comprising 6 study visits over 31 days. The study included an initial screening visit and 30 days of BID dosing. Subjects received their first dose of run-in solution at Visit 1. Subjects received their first dose of randomized study drug at Visit 2 and were dispensed a 2-week daily diary at Visits 2 and 3 with which to enter the details of daily dosing and symptomatology. The CAE was administered at Visit 1 and Visit 4. Visits 2 and 3 were the 24-hour follow-up and 14-day follow-up, respectively, for the CAE at Visit 1. Visits 5 and 6 were the 24-hour follow-up and 48-hour follow-up, respectively, for the CAE at Visit 4. Dry eye signs and symptoms were assessed at all visits.
Subjects receiving RGN-259 saw statistically significant improvements in both their signs and symptoms. There was a significant reduction in central corneal fluorescein staining at Visit 5 from baseline compared to placebo (p=0.0075). There was also a greater reduction in exacerbation of ocular discomfort at Visit 4 during a 75-minute challenge in the CAE compared to the placebo group (p=0.0244). From Visit 1 to Visit 4 RGN-259 showed a statistically significant reduction in superior corneal fluorescein staining (p=0.0210), and showed positive trends in reduction of inferior corneal fluorescein staining (p=0.0968).
The reduction of fluorescein staining is indicative of a reduction in ocular surface damage of the cornea. Furthermore, the statistically significant symptom improvements indicate that RGN-259 can slow the exacerbation of ocular symptoms in patients with dry eye. These results reflect the reported mechanisms of action of RGN-259 and conclude that it is safe and well-tolerated.
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