PURPOSE:Vernal keratoconjunctivitis (VKC) is a bilateral, chronic, external ocular inflammatory disorder that mainly affects patients in their first or second decade. This study was designed to compare tacrolimus and interferonalpha-2b (IFN alpha-2b) eye drops in the treatment of VKC. METHODS: In this randomized, double-masked clinical trial, 40 consecutive patients with VKC were sent to a referral eye hospital in a tropical region southeast of Iran. Patients were randomly assigned to receive either 0.005% tacrolimus or IFNalpha-2b (1,000,000 units/cc). Chi-square and t tests were used for comparison of outcomes between both groups. RESULTS:Mean ± SD age was 11.1 ± 5.2 years. Thirty-one patients (77.5%) were male. The mean duration of disease was 3.4 ± 2.9 years. In this study, the signs and symptoms were significantly reduced in patients after treatment in both groups (P = 0.0001). In the tacrolimus group, all patients responded to treatment whereas only one subject in the IFN group failed to respond (P = 0.99). Side effects in both groups were mild and tolerable. CONCLUSIONS: This study indicated that both 0.005% tacrolimus and IFN alpha-2b are effective and appear to be safe in treatment of recalcitrant VKC.
RCT Entities:
PURPOSE:Vernal keratoconjunctivitis (VKC) is a bilateral, chronic, external ocular inflammatory disorder that mainly affects patients in their first or second decade. This study was designed to compare tacrolimus and interferon alpha-2b (IFN alpha-2b) eye drops in the treatment of VKC. METHODS: In this randomized, double-masked clinical trial, 40 consecutive patients with VKC were sent to a referral eye hospital in a tropical region southeast of Iran. Patients were randomly assigned to receive either 0.005% tacrolimus or IFN alpha-2b (1,000,000 units/cc). Chi-square and t tests were used for comparison of outcomes between both groups. RESULTS: Mean ± SD age was 11.1 ± 5.2 years. Thirty-one patients (77.5%) were male. The mean duration of disease was 3.4 ± 2.9 years. In this study, the signs and symptoms were significantly reduced in patients after treatment in both groups (P = 0.0001). In the tacrolimus group, all patients responded to treatment whereas only one subject in the IFN group failed to respond (P = 0.99). Side effects in both groups were mild and tolerable. CONCLUSIONS: This study indicated that both 0.005% tacrolimus and IFN alpha-2b are effective and appear to be safe in treatment of recalcitrant VKC.
Authors: Xurxo García-Otero; Victoria Díaz-Tomé; Rubén Varela-Fernández; Manuel Martín-Pastor; Miguel González-Barcia; José Blanco-Méndez; Cristina Mondelo-García; Maria A Bermudez; Francisco Gonzalez; Pablo Aguiar; Anxo Fernández-Ferreiro; Francisco J Otero-Espinar Journal: Pharmaceutics Date: 2021-01-23 Impact factor: 6.321