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J. Tauber, W.F. Davitt, J.E. Bokosky, K.K. Nichols, M.C. Mills-Wilson, A.E. Schaberg, B.R. Yerxa, L.M. LaVange, S.J. Kenny, D.J. Kellerman; Double Masked, Placebo-controlled Safety and Efficacy Trial of Diquafosol Tetrasodium (INS365) Ophthalmic Solution for the Treatment of Dry Eye . Invest. Ophthalmol. Vis. Sci. 2003;44(13):3738.
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Purpose: To compare the safety and efficacy of two concentrations of diquafosol tetrasodium (INS365) ophthalmic solution (1.0 and 2.0%) vs. placebo in 527 patients with dry eye. Methods: After qualification, eligible patients with moderate to severe dry eye were randomly assigned to one of the two concentrations of diquafosol or placebo for 24 weeks of treatment. Patients were evaluated in the clinic at weeks 2, 4, 6, 8, 10, 12, 24 and 25 weeks. Results: Corneal staining significantly improved in both diquafosol treatment groups compared to placebo at weeks 2, 4, 6, 12 and 24 (p<0.05). Conjunctival staining also significantly improved in the diquafosol treatment groups compared to placebo at various time points througout the study. Improvement in each subject's "worst" symptom appeared greater at all time points for the 2.0% diquafosol treatment group compared to placebo, with statistical significance noted at weeks 4 and 11 (p<0.05). Although 1.0% diquafosol was superior to placebo with respect to several key endpoints, 2.0% diquafosol was generally more effective than 1.0% diquafosol. Tolerability was excellent in all treatment groups; only 3% of subjects on diquafosol withdrew from the study due to adverse events. Conclusions: The 2.0% diquafosol tetrasodium (INS365) ophthalmic solution was effective and well-tolerated for the treatment of patients with dry eye.
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