A Double-Masked Comparison Of 0.1% Tacrolimus Ointment And 2% Cyclosporine Eye Drops As First Line Drugs in the Treatment of Vernal Keratoconjunctivitis

Abstract

This study was carried out to compare the efficacy of 0.1% Tacrolimus (FK-506) ophthalmic eye ointment with 2% Cyclosporine eye drops in the treatment of VKC. Two groups of VKC diagnosed patients was taken for study-Group A:36 patients received 0.1% tacrolimus eye ointment and Group B:36 patients received 2% cyclosporine eye drops. The study was conducted in Ophthalmology Department, Rajindra Hospital, Patiala. Patients fulfilling the inclusion criteria and after verifying the exclusion criteria were enrolled in the study. The main outcome measures were scoring and comparison of Total subjective symptom scores (TSSS) and Total objective ocular sign scores (TOSS) within and between the Groups at each follow up. With treatment both TSSS and TOSS decreased consistently in both groups without any adverse effects but an increase in scores was noticed within two weeks after drug withdrawl. Both drugs are equally effective and safe in VKC but with a short lasting effect. I. Introduction Vernal keratoconjunctivitis (VKC) is a chronic sight-threatening inflammatory eye disease commonly observed in children and adolescents. VKC usually occurs before 10 years of age. The disease generally lasts 2-10 years and ordinarily resolves by puberty. [1]

Efficacy of 0.03% Dermatological Tacrolimus Ointment for Refractory Vernal Keratoconjunctivitis.

“…To prevent the occurrence of steroid-induced complications in VKC patients, certain immunomodulators are in use. 6 Two being cyclosporine and tacrolimus, of which tacrolimus is strong, nonsteroidal, macrolide immunomodulator isolated from Streptomyces tsukubaensis that has 100 times more potency than cyclosporine 7 . Though uncertainty exists about its mechanism of action but it is known to interact with 12-kDa FK506-binding protein in T-cells and thus inhibits calcineurin activity that ultimately leads to reduced de-phosphorylation of the nuclear factor of activated T-cells and hence TH1 (IL-2, interferon-γ), as well as TH2 cytokines (IL-4, IL-5) production is reduced 8 .…”

Efficacy of topical cyclosporine 0.5% in vernal keratoconjuctivitis.

“…Furthermore, there was an improvement in objective signs such as conjunctival hyperemia, conjunctival papillary hypertrophy, giant papillae, limbal hypertrophy, corneal punctate epithelial erosions, and corneal pannus. 28 In the research conducted by Ganjoo S and their team, they conducted a comparative analysis between loteprednol etabonate 0.5% and cyclosporin-A 0.05% as treatments for VKC. Their findings indicate that loteprednol etabonate and cyclosporin-A 0.05% were equally effective in severe VKC.…”

The Efficacy of Topical Tacrolimus Ointment 0.03% as Monotherapy for the Treatment of Severe Cases of Vernal Keratoconjunctmtis

“…This may have been due to the nature n~ the ointment which is a dermatological preparatioo (Protopic®) and not an ophthalmic preparation (as~ is not available in Libya), and is consistent with tlie reports from other researchers. [14, 20,211 • Many studies used different concentrations of tacrolimus with more frequent applications, but this study used the 0.03% concentration applied only once at night which had the advantage of increasing the compliance of patients. Tacrolimus ointment 0.03% is an effective and safe drug that can be used to alleviate the symptoms and signs of severe cases of VKC, and as an alternative to topical corticosteroids.…”