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Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis

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ClinicalTrials.gov Identifier: NCT00987467
Recruitment Status : Completed
First Posted : October 1, 2009
Results First Posted : October 8, 2013
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
Esen K. Akpek, Johns Hopkins University

Brief Summary:

Atopic keratoconjunctivitis (AKC) is a rare type of ocular allergy that is often associated with eczema. Over time, the complications from this disease process lead to loss of vision due to continual scarring of the corneal surface. The pathophysiology of AKC has not been fully elucidated, and the triggers are still unknown.

Corticosteroids are very effective in controlling the acute symptoms of AKC. However, two thirds of patients managed with a combination of oral antihistamine, topical mast cell stabilizer, and intermittent topical steroid regimen eventually developed significant keratopathy and vision loss. Additionally, there are many side effects of corticosteroids, including local immunosuppression, cataract formation, and increased risk of glaucoma.

Cyclosporin A is an immunomodulator that specifically inhibits T lymphocytes by blocking the expression of the interleukin-2 receptor. It also blocks the release of inflammatory mediators from mast cells and eosinophils. Cyclosporin has no known side effects except for burning upon instillation, and safe to use over long-term . The investigators have demonstrated that a 0.05% ophthalmic emulsion of cyclosporine has been shown to be effective at improving the ocular signs and symptoms of AKC over short-term. However, the long-term efficacy of cyclosporine A in slowing the natural history of AKC and possible steroid sparing effects have not been assessed. The investigators hypothesize that cyclosporine A can be used as a mainstay treatment of AKC to control signs and symptoms over a long period of time and also prevent the progression of this disease.


Condition or disease Intervention/treatment
Atopic Keratoconjunctivitis Drug: Cyclosporin 0.05% ophthalmic

Detailed Description:

Atopic keratoconjunctivitis (AKC) is a rare type of ocular allergy that is often associated with eczema. Over time, the complications from this disease process lead to loss of vision due to continual scarring of the corneal surface. The pathophysiology of AKC has not been fully elucidated, and the triggers are still unknown.

Corticosteroids are very effective in controlling the acute symptoms of AKC. However, two thirds of patients managed with a combination of oral antihistamine, topical mast cell stabilizer, and intermittent topical steroid regimen eventually developed significant keratopathy and vision loss. Additionally, there are many side effects of corticosteroids, including local immunosuppression, cataract formation, and increased risk of glaucoma.

Cyclosporin A is an immunomodulator that specifically inhibits T lymphocytes by blocking the expression of the interleukin-2 receptor. It also blocks the release of inflammatory mediators from mast cells and eosinophils. Cyclosporin has no known side effects except for burning upon instillation, and safe to use over long-term . The investigators have demonstrated that a 0.05% ophthalmic emulsion of cyclosporine has been shown to be effective at improving the ocular signs and symptoms of AKC over short-term. However, the long-term efficacy of cyclosporine A in slowing the natural history of AKC and possible steroid sparing effects have not been assessed. The investigators hypothesize that cyclosporine A can be used as a mainstay treatment of AKC to control signs and symptoms over a long period of time and also prevent the progression of this disease.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Results of Topical Cyclosporine 0.05% in the Treatment of Atopic Keratoconjunctivitis
Study Start Date : August 2007
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cyclosporine 0.05% ophthalmic
Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.
Drug: Cyclosporin 0.05% ophthalmic
Cyclosporine 0.05% ophthalmic solution, 1 drop 6 times in both eyes daily for first month, then 1 drop 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator.
Other Name: Restasis
Drug: Cyclosporin 0.05% ophthalmic
ophthalmic topical eye drop
Other Name: restasis



Primary Outcome Measures :
  1. Ocular Symptoms and Signs Total Composite Score [ Time Frame: Baseline and 8 weeks ]
    Symptoms (itching, tearing, discomfort, discharge, photophobia) and signs (Bublar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) evaluated on a 4 point scale of 0-3, with a minimum symptom score of 0- maximum 15, and sign score minimum 0-maximum 18, and total composite score of signs and symptoms of minimum 0-maximum 33. The highest score would indicate the most severe case of AKC.


Secondary Outcome Measures :
  1. Corticosteroid Usage [ Time Frame: 12 months or longer ]
    Number of flare-ups requiring topical steroid-use across all participants over the entire 12 month follow-up period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has known diagnosis of atopic keratoconjunctivitis
  • Patient has been on cyclosporine 0.05% eye drops for control of atopic keratoconjunctivitis
  • Patient has been followed up for at least for 1 year
  • Patient is able to give informed consent
  • Patient is able to tolerate a full ophthalmic exam

Exclusion Criteria:

  • Patient has any other diagnosis (i.c. vernal keratoconjuntivitis, giant papillary conjunctivitis) that may alter the clinical appearance or behavior of their ocular surface)

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): NCT00987467


Locations
United States, Maryland
Johns Hopkins Hospital - Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Esen K Akpek, MD Johns Hopkins Hospital - Wilmer Eye Institute

Publications:
Responsible Party: Esen K. Akpek, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00987467     History of Changes
Other Study ID Numbers: NA_00010864
First Posted: October 1, 2009    Key Record Dates
Results First Posted: October 8, 2013
Last Update Posted: October 8, 2013
Last Verified: October 2013

Keywords provided by Esen K. Akpek, Johns Hopkins University:
Atopic
Keratoconjunctivitis
Restasis
Cyclosporine

Additional relevant MeSH terms:
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors