Vernal Keratoconjunctivitis
Conditions
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.
Interventions
Topical tacrolimus 0.01% twice daily for one month
Sponsors
The Eye Center and The Eye Foundation for Research in Ophthalmology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Saudi Arabia
Contacts
Primary ContactSamir S Shoughy
Backup ContactKhalid F Tabbara
Outcome results
None listed