Treatment of chronic nonbacterial conjunctivitis with a cyclo-oxygenase inhibitor or a corticosteroid. Pranoprofen Study Group.
A multicenter, double-masked, parallel-group clinical trial was carried out in 151 patients with moderate to severe chronic conjunctivitis. The study compared the antiinflammatory efficacy and safety of pranoprofen 0.1%, a new cyclo-oxygenase inhibitor, with fluorometholone 0.1%, after topical doses four times a day for 15 days. The basal mean score for the signs and symptoms of inflammation, was significantly reduced (P < .001), with no significant difference between the two groups, at days 8 and 15. There was a statistically significant difference of approximately 1.0 mm Hg (P < .05) in the mean intraocular pressure between treatment, which was a decrease of 0.3 mm Hg with pranoprofen and an increase of 0.8 mm Hg with fluorometholone. One patient in the pranoprofen group had an adverse experience, compared to nine patients in the fluorometholone group (P < .03). Our data suggest that pranoprofen has efficacy equivalent to a moderate-potency corticosteroid with a better safety profile. It should be considered for the treatment of chronic conjunctivitis of presumed nonbacterial origin.
Notivol
R
R
Department of Ophthalmology, Research and Development, Laboratorios Cusí S.A., El Masnou, Spain.
Martínez
M
M
Bergamini
M V
MV
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D001578:Benzopyrans / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D003231:Conjunctivitis / Q000188:drug therapy*; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005469:Fluorometholone / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011422:Propionates / Q000009:adverse effects / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D001578:Benzopyrans; D016861:Cyclooxygenase Inhibitors; D009883:Ophthalmic Solutions; D011422:Propionates; C043940:pyranoprofen; D005469:Fluorometholone