American Journal of Ophthalmology
Volume 149, Issue 4 , Pages 594-601 , April 2010

Demonstration of Efficacy in the Treatment of Dry Eye Disease with 0.18% Sodium Hyaluronate Ophthalmic Solution (Vismed, Rejena)

  • Roger Vogel

      Affiliations

    • Rx Development Resources, LLC, Tampa, Florida
    • ,
  • R. Stephens Crockett

      Affiliations

    • Design and Analysis of Trials Associates, Inc, Grand Bay, Alabama
    • ,
  • Neal Oden

      Affiliations

    • The EMMES Corporation, Rockville, Maryland
    • ,
  • Terry W. Laliberte

      Affiliations

    • Lantibio, Inc, Chapel Hill, North Carolina
    • ,
  • Luis Molina

      Affiliations

    • Lantibio, Inc, Chapel Hill, North Carolina
    • Corresponding Author InformationInquiries to Luis Molina, PhD, Lantibio, Inc, 100 Europe Dr, Suite 421, Chapel Hill, NC 27517
    • ,
  • Sodium Hyaluronate Ophthalmic Solution Study Group

,Accepted 30 September 2009.

References 

  1. Report of the Epidemiology Subcommittee of the International Dry Eye Work Shop: The epidemiology of dry eye disease. Ocul Surf. 2007;5:93–107
  2. Report of the Definition and Classification Subcommittee of the International Dry Eye Work Shop: The definition and classification of dry eye disease. Ocul Surf. 2007;5:75–92
  3. Lemp MA. Advances in understanding and managing dry eye disease. Am J Ophthalmol. 2008;146:350–356
  4. Report of the Management and Therapy Subcommittee of the International Dry Eye Work Shop: Management and therapy of dry eye disease. Ocul Surf. 2007;5:163–178
  5. Bron A. Duke-Elder Lecture (Prospects for the dry eye). Trans Ophthalmol Soc. 1985;104:801–826
  6. Tiffany J. Viscoelastic properties of human tears and polymer solutions. Adv Exp Med Biol. 1994;350:267–270
  7. Nakamura M, Hikida M, Nakano T, et al. Characterization of water retentive properties of hyaluronan. Cornea. 1993;12(5):433–436
  8. Saettone MF, Chetoni P, Torracca MT, et al. Evaluation of muco-adhesive properties and in vivo activity of ophthalmic vehicles based on hyaluronic acid. Int J Pharm. 1989;51:203–212
  9. Tiffany JM. Composition and biophysical properties of the tear film: knowledge and uncertainty. Adv Exp Med Biol. 1994;350:231–238
  10. Lehmann EL, D'Abrera HJM. Blocked comparisons for two treatments. In:  Lehmann EL editors. Nonparametric statistical methods based on ranks. San Francisco: McGraw-Hill; 1975;p. 132–135145,154
  11. Shuster JJ. Diagnostics for assumptions in moderate to large simple clinical trials: do they really help?. Stat Med. 2005;24:2431–2438
  12. Foulks GN. Challenges and pitfalls in clinical trials of treatments for dry eye. Ocul Surf. 2003;1:20–30
  13. Report of the Clinical Trials Subcommittee of the International Dry Eye Work Shop. Design and conduct of clinical trials. Ocul Surf. 2007;5:153–162
  14. Johnson ME, Murphy PJ, Boulton M. Carbomer and sodium hyaluronate eyedrops for moderate dry eye treatment. Optom Vis Sci. 2008;85:750–757
  15. Montés-Mico R, Caliz A, Alio JL. Changes in ocular aberrations after instillation of artificial tears in dry-eye patients. J Cataract Refract Surg. 2004;30:1649–1652
  16. Patel S. The management of dry-eye problems. Optician. 2001;221:26–32
  17. Prabhasawat P, Tesavibul N, Kasetsuwan N. Performance profile of sodium hyaluronate in patients with lipid tear deficiency: randomised, double-blind, controlled, exploratory study. Br J Ophthalmol. 2007;91:47–50
  18. Brignole F, Pisella PJ, Dupas B, et al. Efficacy and safety of 0.18% sodium hyaluronate in patients with moderate dry eye syndrome and superficial keratitis. Graefes Arch Clin Exp Ophthalmol. 2005;243:531–538

PII: S0002-9394(09)00736-3

doi: 10.1016/j.ajo.2009.09.023

American Journal of Ophthalmology
Volume 149, Issue 4 , Pages 594-601 , April 2010

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