Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Esen K. Akpek, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00987467
First received: September 30, 2009
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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 Intervention
Atopic Keratoconjunctivitis
Drug: Cyclosporin 0.05% ophthalmic

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Results of Topical Cyclosporine 0.05% in the Treatment of Atopic Keratoconjunctivitis

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Ocular Symptoms and Signs Total Composite Score [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Corticosteroid Usage [ Time Frame: 12 months or longer ] [ Designated as safety issue: No ]
    Number of flare-ups requiring topical steroid-use across all participants over the entire 12 month follow-up period


Enrollment: 12
Study Start Date: August 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Esen K. Akpek, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00987467     History of Changes
Other Study ID Numbers: NA_00010864
Study First Received: September 30, 2009
Results First Received: April 15, 2013
Last Updated: October 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 20, 2014