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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

Page last updated: August 20, 2015

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