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Topical Tacrolimus in Vernal Keratoconjunctivitis

Sponsor
The Eye Center and The Eye Foundation for Research in Ophthalmology (Other)
Overall Status
Unknown status
CT.gov ID
NCT02456025
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
44
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Topical tacrolimus
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Topical Tacrolimus in Vernal Keratoconjunctivitis
Study Start Date :
Apr 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Eye Center Riyadh Saudi Arabia

    Sponsors and Collaborators

    • The Eye Center and The Eye Foundation for Research in Ophthalmology

    Investigators

    • Principal Investigator: Samir S Shoughy, THE EYE CENTER

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samir S. Shoughy, MD, FRCS (Glasg.), Ophthalmologist, The Eye Center and The Eye Foundation for Research in Ophthalmology
    ClinicalTrials.gov Identifier:
    NCT02456025
    Other Study ID Numbers:
    • TEC 124
    First Posted:
    May 28, 2015
    Last Update Posted:
    Nov 24, 2015
    Last Verified:
    Nov 1, 2015
    Additional relevant MeSH terms:
    Keratoconjunctivitis
    Conjunctivitis, Allergic
    Tacrolimus

    Study Results

    No Results Posted as of Nov 24, 2015