title: The effect of diclofenac sodium on the initial comfort of RGP contact lenses: a pilot study.
abstract: BACKGROUND
  We conducted a pilot study to assess the effect of 0.1% diclofenac sodium eyedrops on the initial comfort of rigid gas permeable (RGP) contact lenses.
  
  
  METHODS
  A double-masked, placebo-controlled, crossover trial was performed on 20 unadapted subjects. In Phase I, subjects used either 0.1% diclofenac or placebo eyedrops four times per day for 3 days before RGP lenses were dispensed. Contact lenses were inserted on Day 4 and worn for 8 continuous hours. Eyedrops were used twice during the 8-hour period. Ocular symptoms were graded on a visual analog scale at six points during the day. Visual acuity and slitlamp examinations were performed at the same six study points. After a 2-week wash-out period, subjects received the opposite treatment in Phase II, following the same protocol used in Phase I.
  
  
  RESULTS
  The treatment effect was tested using the Mainland-Gart chi-square test. There was no statistically significant treatment effect (chi-square = 0.20, p = 0.653) on patient symptoms. Biomicroscopy findings were analyzed and, likewise, showed no significant treatment effect (chi-square = 2.10, p = 0.15).
  
  
  CONCLUSIONS
  Data from this pilot study showed no statistically significant reduction in symptoms or signs with diclofenac eyedrops.
authors.affiliation: School of Optometry, University of Alabama at Birmingham, USA.
authors.forename: A
authors.initials: A
authors.lastname: Gordon
authors.forename: J D
authors.initials: JD
authors.lastname: Bartlett
authors.forename: M
authors.initials: M
authors.lastname: Lin
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D003261:Contact Lenses / Q000009:adverse effects*; D018592:Cross-Over Studies; D004008:Diclofenac / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D010146:Pain / Q000188:drug therapy* / Q000209:etiology*; D010865:Pilot Projects
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D009883:Ophthalmic Solutions; D004008:Diclofenac