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

American Journal of Ophthalmology

Volumn 149, Issue 4, 2010, Pages 594-601

  Vogel, Roger ^a   Crockett, R Stephens ^b   Oden, Neal ^c   Laliberte, Terry W ^d   Molina, Luis ^d  

^a Rx Development Resources LLC   (United States)

^b Design and Analysis   (United States)

^c EMMES CORPORATION   (United States)

^d Lantibio Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EYE DROPS; HYALURONIC ACID; PLACEBO;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRY EYE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM;

ADMINISTRATION, TOPICAL; COLORING AGENTS; CORNEA; DOUBLE-BLIND METHOD; DRY EYE SYNDROMES; FEMALE; FLUOROPHOTOMETRY; HUMANS; HYALURONIC ACID; LISSAMINE GREEN DYES; MALE; MIDDLE AGED; OPHTHALMIC SOLUTIONS; STAINING AND LABELING; TREATMENT OUTCOME; VEHICLES; VISUAL ACUITY;

EID: 77949603357     PISSN: 00029394     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ajo.2009.09.023     Document Type: Article

References (18)

1. Report of the Epidemiology Subcommittee of the International Dry Eye Work Shop: The epidemiology of dry eye disease. Ocul Surf 5 (2007) 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 5 (2007) 75-92
3. Lemp M.A. Advances in understanding and managing dry eye disease. Am J Ophthalmol 146 (2008) 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 5 (2007) 163-178
5. Bron A. Duke-Elder Lecture. Prospects for the dry eye. Trans Ophthalmol Soc 104 (1985) 801-826
6. Tiffany J. Viscoelastic properties of human tears and polymer solutions. Adv Exp Med Biol 350 (1994) 267-270
7. Nakamura M., Hikida M., Nakano T., et al. Characterization of water retentive properties of hyaluronan. Cornea 12 5 (1993) 433-436
8. Saettone M.F., Chetoni P., Torracca M.T., et al. Evaluation of muco-adhesive properties and in vivo activity of ophthalmic vehicles based on hyaluronic acid. Int J Pharm 51 (1989) 203-212
9. Tiffany J.M. Composition and biophysical properties of the tear film: knowledge and uncertainty. Adv Exp Med Biol 350 (1994) 231-238
10. Lehmann E.L., and D'Abrera H.J.M. Blocked comparisons for two treatments. In: Lehmann E.L. (Ed). Nonparametric statistical methods based on ranks (1975), McGraw-Hill, San Francisco 132-135 145,154
11. Shuster J.J. Diagnostics for assumptions in moderate to large simple clinical trials: do they really help?. Stat Med 24 (2005) 2431-2438
12. Foulks G.N. Challenges and pitfalls in clinical trials of treatments for dry eye. Ocul Surf 1 (2003) 20-30
13. Report of the Clinical Trials Subcommittee of the International Dry Eye Work Shop. Design and conduct of clinical trials. Ocul Surf 5 (2007) 153-162
14. Johnson M.E., Murphy P.J., and Boulton M. Carbomer and sodium hyaluronate eyedrops for moderate dry eye treatment. Optom Vis Sci 85 (2008) 750-757
15. Montés-Mico R., Caliz A., and Alio J.L. Changes in ocular aberrations after instillation of artificial tears in dry-eye patients. J Cataract Refract Surg 30 (2004) 1649-1652
16. Patel S. The management of dry-eye problems. Optician 221 (2001) 26-32
17. Prabhasawat P., Tesavibul N., and Kasetsuwan N. Performance profile of sodium hyaluronate in patients with lipid tear deficiency: randomised, double-blind, controlled, exploratory study. Br J Ophthalmol 91 (2007) 47-50
18. Brignole F., Pisella P.J., 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 243 (2005) 531-538