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G. W. Ousler, III, D. Power, M. Schindelar, D. Welch, M. B. Abelson; A Phase II Double-Masked, Randomized, Parallel-Group Study to Assess the Safety and Efficacy of ALTY-0501 (Doxycycline 0.025% Ophthalmic Solution) in Dry Eye Patients Exposed to the Controlled Adverse Environment (CAE). Invest. Ophthalmol. Vis. Sci. 2008;49(13):102.
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This study was designed to evaluate the safety and potential treatment benefit of ALTY-0501 for dry eye. The study used the controlled adverse environment (CAE), a clinical model which allows for standardized measurement of dry eye signs and symptoms in the investigation of therapeutic agents.
One hundred sixty (160) patients were randomized to receive ALTY-0501 eye drops or its vehicle QID in a 56-day, double-masked, randomized, parallel-group Phase II trial. Dry eye patients were exposed to the CAE on day 1 and again at follow-up visits on days 28 and 56. Signs and symptoms of dry eye were assessed before, during, and after exposure to the CAE at each of these visits. Patients instilled study medications QID over 56 days, and recorded symptom severity measurements on a daily basis in a diary throughout the study.
The study did not reach statistical significance for the primary efficacy variables of change in central corneal fluorescein staining after CAE exposure and the symptom of ocular dryness at day 56. Patients who received active treatment however had statistically significantly lower fluorescein staining scores for the total cornea and conjunctiva as well as for the superior and nasal sub-regions following CAE exposure than those receiving vehicle (p < 0.05) on day 28. The active group also exhibited statistically significant benefits compared to vehicle in patient diary scores for symptoms of burning (p < 0.0001), stinging (p < 0.0001), and grittiness (p < 0.0001) over the study period.
ALTY-0501 demonstrated statistically significant advantages over vehicle in managing the signs and symptoms of dry eye. The findings merit further study of the efficacy of ALTY-0501 in the treatment of dry eye.
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