A comparison of two different formulations of diclofenac sodium 0.1% in the treatment of inflammation following cataract-intraocular lens surgery.
OBJECTIVE
To compare the efficacy, tolerability and local tolerance of diclofenac sodium 0.1% containing hydroxypropylgamma cyclodextrin preserved with benzalkonium chloride 0.005% (Voltaren Ophtha CD), with that of diclofenac sodium 0.1% preserved with thiomersal 0.004% (Voltaren Ophtha) in the treatment of inflammation after cataract-intraocular lens surgery.


METHODS
Randomised 2:1, double-masked, parallel-group study in six centres in Germany.


METHODS
299 patients scheduled to undergo phacoemulsification with posterior chamber intraocular lens implantation.


METHODS
Study medications were instilled four times in the 30 minutes before surgery and four times daily from the first postoperative day.


METHODS
The key efficacy variable was the reduction in anterior chamber flare (photons/millisecond) from day 1 to day 6 to 8. Patients underwent comprehensive ocular examinations, including laser flaremetry (KOWA), preoperatively and postoperatively at days 1, 6 to 8 and 24 to 32.


RESULTS
268 patients (Voltaren Ophtha CD 177, Voltaren Ophtha 91) completed the day 6 to 8 visit without any protocol violations. Reduction in the degree of intraocular inflammation with Voltaren Ophtha CD was equivalent to that achieved with Voltaren Ophtha at the day 6 to 8 [95% confidence interval (CI) -3.07 to +0.54] and day 24 to 32 (95% CI -1.44 to +1.40) visits. Although there was no significant (p = 0.464) difference between the two study groups in patients' global assessment of local tolerance at day 24 to 32, ocular discomfort was significantly (p = 0.023) less with Voltaren Ophtha CD compared with Voltaren Ophtha.


CONCLUSIONS
Voltaren Ophtha CD was as effective and well tolerated but had less ocular discomfort compared with Voltaren Ophtha in the treatment of ocular inflammation after phacoemulsification with intraocular lens implantation. This new formulation of diclofenac sodium 0.1% may be used as an alternative to the existing formulations of ophthalmic diclofenac sodium 0.1%.
Mester
Ulrich
U
Knappschaftskrankenhaus, Sulzbach, Germany.
Lohmann
Chris
C
Pleyer
U
U
Steinkamp
G
G
Völcker
E
E
Kruger
H
H
Raj
Palaniswamy Sunder
PS
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000867:Anterior Chamber / Q000503:physiopathology; D001548:Benzalkonium Compounds / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use; D002387:Cataract Extraction / Q000009:adverse effects* / Q000706:statistics & numerical data; D002626:Chemistry, Pharmaceutical; D004008:Diclofenac / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007249:Inflammation / Q000188:drug therapy* / Q000503:physiopathology; D019654:Lens Implantation, Intraocular / Q000009:adverse effects* / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013849:Thimerosal / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use
D001548:Benzalkonium Compounds; D004008:Diclofenac; D013849:Thimerosal