Topical Tacrolimus in Vernal Keratoconjunctivitis

Vernal Keratoconjunctivitis Clinical Trial

Official title:

Topical Tacrolimus in Vernal Keratoconjunctivitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02456025
• Other study ID #: TEC 124
• Status: Recruiting
• Phase: Phase 4
• First received: August 18, 2013
• Last updated: November 22, 2015
• Start date: April 2013
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: The Eye Center and The Eye Foundation for Research in Ophthalmology
• Contact: Samir S Shoughy
• Phone: 0096614649614
• Email: samir.shawki[@]hotmail.com
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis, Allergic
• Keratoconjunctivitis
• Vernal Keratoconjunctivitis

Intervention

Drug:
• Topical tacrolimus
Topical tacrolimus 0.01% twice daily for one month

Locations

Country	Name	City	State
Saudi Arabia	The Eye Center	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
The Eye Center and The Eye Foundation for Research in Ophthalmology

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of Topical Tacrolimus in Vernal Keratoconjunctivitis	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	Five months	No