A randomized, controlled trial to investigate the effect of ciclesonide and beclomethasone dipropionate on eye lens opacity.
BACKGROUND
Inhaled corticosteroids (ICS) are recommended first-line therapy for the treatment of persistent asthma. However, reports from observational studies have suggested that the use of ICS may be associated with systemic adverse events, such as glaucoma and cataract (opacity of the lens) formation.


OBJECTIVE
To compare two ICS over 1 year regarding the formation/progression of lenticular opacities in patients with asthma.


METHODS
Adults (>or=18 years of age) with moderate-to-severe asthma were randomized to ciclesonide 640 micro g/day (n = 785) or beclomethasone dipropionate 640 micro g/day (n = 783) in a multinational, double-blind, active-controlled, parallel-group study. The primary endpoint was the occurrence of a positive Class I grading shift (increase [worsening] in Lens Opacities Classification System [LOCS] III score of >or= 0.5 for nuclear opalescence, >or= 0.8 for cortical opacification, or >or= 0.5 for posterior subcapsular opacification, or cataract surgery) in either eye at any visit over the 12-month, double-blind treatment period.


RESULTS
Mean changes (+/- standard error) in nuclear opalescence and cortical and posterior subcapsular opacification were small and similar between groups (ciclesonide 640 micro g/day: 0.10 +/- 0.02, 0.07 +/- 0.02 and 0.04 +/- 0.01, respectively; beclomethasone dipropionate 640 micro g/day: 0.11 +/- 0.02, 0.09 +/- 0.02 and 0.03 +/- 0.01, respectively). Class I shifts were observed in 34.3% versus 36.8% of ciclesonide-treated and beclomethasone dipropionate-treated patients, respectively. Ciclesonide 640 micro g/day was non-inferior to beclomethasone dipropionate 640 micro g/day regarding Class I shifts (risk ratio of ciclesonide to beclomethasone dipropionate, 0.940 [95% confidence interval, 0.820-1.077]); the 95% confidence interval upper bound was lower than the pre-specified non-inferiority bound of 1.333 (p < 0.0001), thereby excluding the possibility of higher risk ratio values.


CONCLUSIONS
Mean changes in LOCS III scores were very small in both groups. Treatment with ciclesonide 640 micro g/day or beclomethasone dipropionate 640 micro g/day for 1 year has a minimal impact on lenticular opacities development and/or progression.
Chylack
Leo T
LT
Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, USA. ltchylack@rics.bwh.harvard.edu
Gross
Gary N
GN
Pedinoff
Andrew
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018926:Anti-Allergic Agents / Q000009:adverse effects*; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000009:adverse effects*; D002386:Cataract / Q000139:chemically induced*; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects*; D006801:Humans; D007908:Lens, Crystalline / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D011282:Pregnenediones / Q000009:adverse effects*; D055815:Young Adult
D018926:Anti-Allergic Agents; D005938:Glucocorticoids; D011282:Pregnenediones; D001507:Beclomethasone; C120481:ciclesonide