A large prospective observational study of novel cyclosporine 0.1% aqueous ophthalmic solution in the treatment of severe allergic conjunctivitis.
OBJECTIVE
To evaluate the effectiveness and safety of a novel cyclosporine 0.1% aqueous ophthalmic solution in a large population with vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).


METHODS
A prospective observational postmarketing study was initiated in Japan. A total of 594 patients with VKC or AKC were started on this drug within 1 year after market launch (January 2006) and completed a 6-month follow-up. These patients were observed clinically, and subjective ocular symptoms (itching, discharge, tearing, photophobia, foreign body sensation, and pain), objective signs (hyperemia, swelling, follicle, papillae, and giant papillae for the tarsal conjunctiva; hyperemia and edema for the bulbar conjunctiva; Trantas dots and swelling for the limbus; and corneal involvement), and adverse events were recorded.


RESULTS
All scores for symptoms and signs significantly decreased from Month 1 through Month 6 of treatment in both VKC and AKC. Median total symptom scores at baseline, Month 1, and Month 6 were 6, 2, and 1, respectively, for VKC, and 7, 3, and 2, respectively, for AKC. Similarly, median total sign scores were 12, 7, and 5, respectively, for VKC, and 14, 10, and 7, respectively, for AKC. The percentage of patients able to complete topical cyclosporine 0.1% therapy within 6 months due to alleviation of symptoms was higher for VKC (44.4%) than for AKC (21.9%). In both VKC and AKC, approximately 30% of steroid users were able to discontinue topical steroids. Adverse drug reactions (ADRs) were found in 12.0% of patients, and the most common ADR was eye irritation (4.4%). Infectious corneal complications were observed in five AKC patients, including two cases of bacterial corneal ulcer and three cases of herpetic keratitis; all of these patients were concomitantly using topical steroids.


CONCLUSIONS
Topical cyclosporine 0.1% is an effective and safe treatment for VKC and AKC.
Ebihara
Nobuyuki
N
Department of Ophthalmology, Juntendo University School of Medicine, 2-1-1 Hongo, Tokyo, Japan. ebihara@med.juntendo.ac.jp
Ohashi
Yuichi
Y
Uchio
Eiichi
E
Okamoto
Shigeki
S
Kumagai
Naoki
N
Shoji
Jun
J
Takamura
Etsuko
E
Nakagawa
Yayoi
Y
Nanba
Kenichi
K
Fukushima
Atsuki
A
Fujishima
Hiroshi
H
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D002648:Child; D003233:Conjunctivitis, Allergic / Q000188:drug therapy* / Q000503:physiopathology; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D007637:Keratoconjunctivitis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D009883:Ophthalmic Solutions; D011446:Prospective Studies; D012720:Severity of Illness Index; D055815:Young Adult
D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D009883:Ophthalmic Solutions; D016572:Cyclosporine