Topical Tacrolimus in Vernal Keratoconjunctivitis

November 22, 2015 updated by: Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology
The main aim of this study is to evaluate the efficacy and safety of topical tacrolimus 0.01% eyedrops in patients with vernal keratoconjunctivitis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Topical tacrolimus
20 eyes with active Vernal Keratoconjunctivitis
Drug: Topical tacrolimus
Topical tacrolimus 0.01% twice daily for one month
Other Names:
  • Tacrolimus eye drops
PLACEBO_COMPARATOR: Placebo
20 eyes with active Vernal Keratoconjunctivitis
Drug: Topical tacrolimus
Topical tacrolimus 0.01% twice daily for one month
Other Names:
  • Tacrolimus eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of Topical Tacrolimus in Vernal Keratoconjunctivitis
Time Frame: 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
Five months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Eye Center and The Eye Foundation for Research in Ophthalmology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

August 18, 2013

First Submitted That Met QC Criteria

May 25, 2015

First Posted (ESTIMATE)

May 28, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 24, 2015

Last Update Submitted That Met QC Criteria

November 22, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEC 124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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