[Ocular tolerance of a new formulation of nonpreserved diclofenac]

J Fr Ophtalmol. 2004 Sep;27(7):739-44. doi: 10.1016/s0181-5512(04)96208-0.
[Article in French]

Abstract

Aim: To compare the ocular tolerance of nonpreserved diclofenac versus thiomersal-preserved diclofenac in healthy volunteers.

Materials and methods: Forty healthy volunteers instilled Dicloabak in the randomised eye and thiomersal-preserved diclofenac in the other eye, according to a strictly identical dosing regimen, for 28 days. Each volunteer thus served as his or her own control. The dose regimen was five drops/day for 7 days followed by three drops/day for 20 days. Ocular tolerance was assessed by the discomfort upon instillation (measured on a visual analogue scale [VAS]), subjective ocular symptoms following instillation (irritation/burning/stinging, eye dryness and foreign body sensation) and finally by an objective examination of the ocular surface. These criteria were evaluated on days 0, 14, 21 and 28.

Results: The subjective ocular symptoms following instillation were significantly lower in the nonpreserved group at Day 7 and nearly significantly lower until the end of the study. The biomicroscopy exam confirmed that there was better tolerance without thiomersal. There was less follicular-papillary conjunctivitis and a significantly better lissamine green score in the Dicloabak group.

Conclusion: The results of this study demonstrate that the nonpreserved formulation of diclofenac is better tolerated by the ocular surface and thus constitutes a therapeutic benefit.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Comparative Study
  • English Abstract
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Diclofenac / administration & dosage*
  • Diclofenac / adverse effects
  • Drug Administration Schedule
  • Dry Eye Syndromes / chemically induced
  • Eye Diseases / chemically induced
  • Female
  • Humans
  • Instillation, Drug
  • Male
  • Ophthalmic Solutions
  • Pain / chemically induced
  • Pain Measurement
  • Patient Acceptance of Health Care
  • Preservatives, Pharmaceutical / administration & dosage
  • Preservatives, Pharmaceutical / adverse effects*
  • Thimerosal / administration & dosage
  • Thimerosal / adverse effects*

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Ophthalmic Solutions
  • Preservatives, Pharmaceutical
  • Diclofenac
  • Thimerosal