Clinical Trial: Topical Tacrolimus in Vernal Keratoconjunctivitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Topical Tacrolimus in Vernal Keratoconjunctivitis

Brief Summary: The main aim of this study is to evaluate the efficacy and safety of topical tacrolimus 0.01% eyedrops in patients with vernal keratoconjunctivitis.

Detailed Summary: A total of 20 patients with bilateral symmetrical vernal keratoconjunctivitis will be included. Each patient will undergo a complete ophthalmologic evaluation. Patient will be placed at random on topical Tacrolimus 0.01% ophthalmic solution in one eye and placebo eyedrops in the fellow eye. Patients will undergo ophthalmologic examination at one week and after one month. Photos will be taken. The outcome measures include graded symptoms, graded signs, and laboratory investigations. Symptoms of itching, redness, foreign body sensation, tearing and discharge following will be recorded before and after treatment. The grading of clinical signs of conjunctival hyperemia, conjunctival papillary hypertrophy, perilimbal infiltrates, Trantas dots, superficial punctate keratopathy will be recorded before and after treatment. Conjunctival surface temperature will be determined before and after treatment. Conjunctival scrapings will be stained with Giemsa and will be assessed before and after therapy and number of eosinophils per hpf will be determined and recorded.
Sponsor: The Eye Center and The Eye Foundation for Research in Ophthalmology

Current Primary Outcome: The efficacy of Topical Tacrolimus in Vernal Keratoconjunctivitis [ Time Frame: Five months ]

To evaluate the efficacy of topical tacrolimus 0.01 eye drops in patients with vernal keratoconjunctivitis in symptoms of redness, itching, foreign body sensation and discharge and signs of conjunctival hyperemia,perlimbal infiltrates, Trantas dots and papillary reaction


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The Eye Center and The Eye Foundation for Research in Ophthalmology

Dates:
Date Received: August 18, 2013
Date Started: April 2013
Date Completion: December 2016
Last Updated: November 22, 2015
Last Verified: November 2015