[Ocular tolerance of a new formulation of nonpreserved diclofenac].
OBJECTIVE
To compare the ocular tolerance of nonpreserved diclofenac versus thiomersal-preserved diclofenac in healthy volunteers.


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.


CONCLUSIONS
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.
Chiambaretta
F
F
Service d'Ophtalmologie, CHU de Clermont-Ferrand, Hôpital Gabriel Montpied, Clermont-Ferrand, France.
Creuzot-Garcher
C
C
Pilon
F
F
Pouliquen
P
P
Rebika
H
H
Dubray
C
C
Rigal
D
D
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D015352:Dry Eye Syndromes / Q000139:chemically induced; D005128:Eye Diseases / Q000139:chemically induced; D005260:Female; D006801:Humans; D007322:Instillation, Drug; D008297:Male; D009883:Ophthalmic Solutions; D010146:Pain / Q000139:chemically induced; D010147:Pain Measurement; D010342:Patient Acceptance of Health Care; D011310:Preservatives, Pharmaceutical / Q000008:administration & dosage / Q000009:adverse effects*; D013849:Thimerosal / Q000008:administration & dosage / Q000009:adverse effects*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D004008:Diclofenac; D013849:Thimerosal