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Topical Tacrolimus in Vernal Keratoconjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02456025
Recruitment Status : Unknown
Verified November 2015 by Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology.
Recruitment status was:  Recruiting
First Posted : May 28, 2015
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology

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
Vernal Keratoconjunctivitis 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

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 Name: 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 Name: Tacrolimus eye drops




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456025


Contacts
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Contact: Samir S Shoughy 0096614649614 samir.shawki@hotmail.com
Contact: Khalid F Tabbara 0096614649614 k.tabbara@nesma.net.sa

Locations
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Saudi Arabia
The Eye Center Recruiting
Riyadh, Saudi Arabia
Contact: Samir S Shoughy    0096614649614    samir.shawki@hotmail.com   
Contact: Khalid F Tabbara    0096614649614    k.tabbara@nesma.net.sa   
Principal Investigator: Samir S Shoughy         
Sponsors and Collaborators
The Eye Center and The Eye Foundation for Research in Ophthalmology
Investigators
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Principal Investigator: Samir S Shoughy THE EYE CENTER

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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    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Keratoconjunctivitis
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action