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 ]
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