May 2003
Volume 44, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2003
Double Masked, Placebo-controlled Safety and Efficacy Trial of Diquafosol Tetrasodium (INS365) Ophthalmic Solution for the Treatment of Dry Eye
Author Affiliations & Notes
  • J. Tauber
    Hunkler Eye Centers, Kansas City, MO, United States
  • W.F. Davitt
    Corona Research Clinical Studies, El Paso, TX, United States
  • J.E. Bokosky
    Eye Care of San Diego, San Diego, CA, United States
  • K.K. Nichols
    Ohio State University College of Optometry, Columbus, OH, United States
  • M.C. Mills-Wilson
    Inspire Pharmaceuticals, Durham, NC, United States
  • A.E. Schaberg
    Inspire Pharmaceuticals, Durham, NC, United States
  • B.R. Yerxa
    Inspire Pharmaceuticals, Durham, NC, United States
  • L.M. LaVange
    Inspire Pharmaceuticals, Durham, NC, United States
  • S.J. Kenny
    Maximum Likelihood Solutions, Chapel Hill, NC, United States
  • D.J. Kellerman
    Maximum Likelihood Solutions, Chapel Hill, NC, United States
  • Footnotes
    Commercial Relationships  J. Tauber, Inspire Pharmaceuticals C; W.F. Davitt, Inspire Pharmaceuticals C; J.E. Bokosky, Inspire Pharmaceuticals C; K.K. Nichols, Inspire Pharmaceuticals C; M.C. Mills-Wilson, Inspire Pharmaceuticals E; A.E. Schaberg, Inspire Pharmaceuticals E; B.R. Yerxa, Inspire Pharmaceuticals E; L.M. LaVange, Inspire Pharmaceuticals E; S.J. Kenny, Inspire Pharmaceuticals C; D.J. Kellerman, Inspire Pharmaceuticals E.
Investigative Ophthalmology & Visual Science May 2003, Vol.44, 3738. doi:
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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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Abstract

Abstract: : 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.

Keywords: clinical (human) or epidemiologic studies: tre • cornea: clinical science • cornea: tears/tear film/dry eye 
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