A Double-Blind Comparison of Efficacy of 0.1% Tacrolimus Opthalmic Ointment and 2% Cyclosporine Eye Drop Vernal Keratoconjunctivitis (vkc)
P. Labcharoenwongs, W. Durongpisitkul, P. Dumrongkigchaiporn, O. Jirapongsananuruk, N. Visitsunthorn, P. Kosrirukvongs, W. Booranapong, P. Vichyanond
Pediatric, Siriraj hospital, Bangkok, Thailand
Rationale: To compare the efficacy of 0.1% tacrolimus (FK-506) ophthalmic ointment and 2% cyclosporine eye drop VKC.Methods: After 2 weeks washout period, 24 cases of VKC were randomized into 2 groups in a double-blinded, parallel fashion. The first group received 0.1% FK-506 eye ointment plus placebo eye drop and the 2nd group received cyclosporine eye drops plus placebo ointment for 8 weeks, follow by open treatment with 0.1% FK-506 eye ointment for 4 weeks in both groups. Subjective ocular symptoms and side effects were scored by patients at the entry, 1st, 4th, 8th and 12th weeks. Objective ocular signs were evaluated by one ophthalmologist.Results: Twenty-four cases (23 boys) of VKC were enrolled with mean ages of 9.61+2.55 years. Mean duration of VKC was 3.07+2.28 years. There was no difference between the two groups in subjective, objective and side effect scores at the entry, 1st, 4th, 8th, and 12th weeks. Compared to baseline, the subjective scores at the 4th and 8th weeks decreased significantly in both groups. In contrast, the objective scores at the 4th and 8th week decreased significantly in FK-506 group only (p = 0.003, p = 0.001, respectively). The side effect scores at the 8th week reduced significantly in the FK-506 group only. (p = 0.004).Conclusions: The efficacy of 0.1% FK-506 eye ointment and cyclosporine are comparable for the treatment of VKC. However, total objective scores (after 4th week) and side effect scores (after 8th week) improves only with FK-506.
ปี 2549, February ปีที่: 117 ฉบับที่ 2 หน้า S168