Topical Tacrolimus in Vernal Keratoconjunctivitis

Phase 4

• Conditions: Vernal Keratoconjunctivitis
• Interventions: Drug: Topical tacrolimus

• Registration Number: NCT02456025
• Lead Sponsor: The Eye Center and The Eye Foundation for Research in Ophthalmology

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 Description

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-08-18
• Study First Submitted QC: 2015-05-25
• Study First Posted: 2015-05-28
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-22
• Last Update Posted: 2015-11-24
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• with bilateral symmetrical palpebral and limbal vernal keratoconjunctivitis
• Patients 6-18 years of age

Exclusion Criteria

• Pregnant patients
• Patients on systemic therapy for other allergic disorders
• Patients who cannot come for follow-up
• Patients who are on other topical medications for other comorbid ocular conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical tacrolimus	Topical tacrolimus	20 eyes with active Vernal Keratoconjunctivitis
Placebo	Topical tacrolimus	20 eyes with active Vernal Keratoconjunctivitis

Primary Outcome Measures

Name	Time	Method
The efficacy of Topical Tacrolimus in Vernal Keratoconjunctivitis	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

Trial Locations

Locations (1)

The Eye Center; 🇸🇦 Riyadh, Saudi Arabia