Topical Tacrolimus in Vernal Keratoconjunctivitis
Information source: The Eye Center and The Eye Foundation for Research in Ophthalmology
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vernal Keratoconjunctivitis
Intervention: Topical tacrolimus (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: The Eye Center and The Eye Foundation for Research in Ophthalmology Official(s) and/or principal investigator(s): Samir S Shoughy, Principal Investigator, Affiliation: THE EYE CENTER
Overall contact: Samir S Shoughy, Phone: 0096614649614, Email: samir.shawki@hotmail.com
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.
Clinical Details
Official title: Topical Tacrolimus in Vernal Keratoconjunctivitis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: The efficacy of Topical Tacrolimus in 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.
Eligibility
Minimum age: 6 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Samir S Shoughy, Phone: 0096614649614, Email: samir.shawki@hotmail.com
The Eye Center, Riyadh, Saudi Arabia; Recruiting Samir S Shoughy, Phone: 0096614649614, Email: samir.shawki@hotmail.com Khalid F Tabbara, Phone: 0096614649614, Email: k.tabbara@nesma.net.sa Samir S Shoughy, Principal Investigator
Additional Information
Starting date: April 2013
Last updated: May 25, 2015
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