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Objective: To compare the efficacy of 0.1% tacrolimus (FK-506) ophthalmic ointment with 2% cyclosporine eye drops in the treatment of vernal keratoconjunctivitis (VKC)., Design: Prospective double-masked randomized comparative trial., Participants: Twenty-four VKC patients were enrolled into the study. Their mean age was 9.61 +/- 2.55 years. Twelve patients were allocated into the FK-506 group and the other twelve into the cyclosporine group. Their baseline characteristics were similar between groups., Methods: After a 2 week run-in period, patients were randomized into 2 groups in a double-masked, parallel fashion. Group A received 0.1% FK-506 eye ointment twice daily with placebo eye drops four times daily for 8 weeks. Group B received 2% cyclosporine eye drops with placebo ointment for the same duration. All patients received an open-treatment with 0.1% FK-506 eye ointment for another 4 weeks. Subjective ocular symptoms and side effects were recorded by patients once daily, during the entire period. Objective ocular signs were evaluated and scored at each follow up visit., Main Outcome Measure: Improvement of total subjective symptom scores per day (TSSS) within group and between groups at various time points., Results: For within group comparison, there was a significant decrease in TSSS, compared to their baselines, at weeks 4 and 8, in both treatment groups. However, no statistical difference in TSSS was noted between groups at any time point. Total ocular sign scores (TOSS) in the FK-506 group decreased significantly at weeks 4 and 8 compared to baseline. Although there was a decrease of TOSS in the cyclosporine group, the difference did not reach statistical significance. Side effect scores reduced significantly in both groups at week 4 compared to their respective baselines (p = 0.034 in the FK506 group and p = 0.003 in the cyclosporine group). There was no significant difference in the comparison between groups on TOSS and side effect scores at any time point of the study. During the open FK-506 period, patients in cyclosporine group showed further reduction of both TSSS and TOSS. However, these changes were not statistically significant (p > 0.05)., Conclusion: 0.1% FK-506 eye ointment and 2% cyclosporine were both effective in treatment of VKC. 0.1% FK-506 could become another viable therapeutic option for VKC.

The objective of this study was to develop a disease-specific questionnaire for patients with rhinoconjunctivitis. All patients were recruited at the Out-Patient Clinic at Siriraj Hospital. Related topics were gathered from several sources, and a list of 63 items was produced. In phase I, the first version of the questionnaire was completed by 363 patients. Forty-eight items were identified by clinical impact analysis during the item removal process, two more questions were then added, giving a total of 50. Two hundred and forty-three patients completed the second version questionnaire in phase II. The average time taken to complete the questionnaire was 6.38 minutes. The item removal process in phase II was achieved by a multi-step process. There were 36 items in the third version questionnaire which consisted of six dimensions and two independent items as follows: symptoms (17 items), physical functioning (3 items), role limitations (3 items), sleep (3 items), social functioning (3 items), emotions (5 items), general health (1 item), and absenteeism (1 item). The scores of each item ranged from 1 to 5; a lower score indicating a better quality of life. Data from the selected 36 items was extracted to test the validity and reliability of the final version. The floor and ceiling effects of the scores for each dimension were low. Multitrait multi-item analysis was conducted to examine construct validity. The scaling success of convergent and divergent validity was 100% and 94%, respectively. Internal consistency determined by Cronbach's alpha coefficient, was satisfactory (0.79-0.87). The study indicates that the questionnaire is suitable for use in clinical settings. While the test results are encouraging, further work needs to be done on the test-retest reliability and on responsiveness.

A prospective, cross-sectional and randomized cross-over study was conducted to study the clinical features and treatment outcome among Thai patients with vernal keratoconjunctivitis (VKC). History-taking and eye examinations were performed. Mild cases of VKC were given topical antihistamine four times daily. Moderate and severe cases of VKC were treated with topical lodoxamide four times a day. Severe cases of VKC were given topical corticosteroids. Moderate and severe cases of VKC, which were refractory to treatment with either corticosteroids or a mast cell stabilizer had topical cyclosporine 0.5% instilled four times daily. Five patients were exposed to two different treatment regimens in sequence. As main outcome measures, itching, foreign body sensation, photophobia, conjunctival injection, papillae and chemosis were evaluated weekly. The patients with the palpebral type of VKC had daily symptoms, which were more severe and triggered by house-dust with a significant difference among the groups. Limbal VKC was associated with allergic rhinitis more commonly than palpebral VKC. Positive results of skin prick testing to acacia, careless weed, mold, Johnson grass and cow's milk were significantly more common in patients with palpebral VKC. The most common symptoms and signs were found in the mixed type of VKC. Purulent discharge, pannus and lid erythema were found in the palpebral type. Levocabastine hydrochloride was sufficient for mild cases of limbal VKC; lodoxamide for the limbal and mixed types. Prednisolone acetate was the drug of choice in severe cases of any type but only for a short period of time. The success rate of topical cyclosporine in the palpebral type was lower than in the limbal type due to an intolerable burning sensation. Topical cyclosporine used in 4 patients with limbal and palpebral type had a success rate of 100% which was greater than in the lodoxamide group (66.7%, 0%). Compared with topical corticosteroid-treated eyes in one patient, the success rate in topical cyclosporine-treated eyes was not success. Grading the severity of each type of VKC is crucial to obtain good response of any medication and compliance. Topical cyclosporine 0.5% can be an alternative drug to relieve symptoms and signs of VKC in order to avoid steroid-induced glaucoma.