Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis

NCT00987467 | Completed Results

• 1 other identifier: NA_00010864
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Keratoconjunctivitis

Keywords

Atopic; Keratoconjunctivitis; Restasis; Cyclosporine

Outcome Measures

Primary Outcomes (1)

• Ocular Symptoms and Signs Total Composite Score

  Symptoms (itching, tearing, discomfort, discharge, photophobia) and signs (Bulbar 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. These scores are combined to yeild a total composite score of signs and symptoms of minimum 0-maximum 33. The highest score would indicate the most severe case of Atopic Keratoconjunctivitis (AKC). The composite score is reported.

  Baseline and 8 weeks

Secondary Outcomes (1)

• Corticosteroid Usage

  Entire follow-up period (Approximately 12 months)

Study Arms (1)

Cyclosporine 0.05% ophthalmic

EXPERIMENTAL

cyclosporine 0.05% ophthalmic eye drops will be used 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 will be adjusted by clinician as needed for appropriate disease control

Drug: Cyclosporin 0.05% ophthalmic

Interventions

Cyclosporin 0.05% ophthalmic DRUG

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.

Also known as: Restasis

Cyclosporine 0.05% ophthalmic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital - Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Akpek EK, Dart JK, Watson S, Christen W, Dursun D, Yoo S, O'Brien TP, Schein OD, Gottsch JD. A randomized trial of topical cyclosporin 0.05% in topical steroid-resistant atopic keratoconjunctivitis. Ophthalmology. 2004 Mar;111(3):476-82. doi: 10.1016/j.ophtha.2003.05.035.

  PMID: 15019322 BACKGROUND

MeSH Terms

Conditions

Keratoconjunctivitis

Interventions

Cyclosporine; Vision, Ocular; Cyclosporins

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Light Signal Transduction; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Cell Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena

Limitations and Caveats

We were not able to have a control group and the treatment was not masked.

Results Point of Contact

• Title: Esen Akpek, MD, Associate Professor of Ophthalmology, Wilmer Eye Institute
• Organization: Johns Hopkins University, Wilmer Eye Institute

esakpek@jhmi.edu

410-955-5214

Study Officials

• Esen K Akpek, MD

  Johns Hopkins Hospital - Wilmer Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2009
• First Posted: October 1, 2009
• Study Start: August 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 2, 2018
• Results First Posted: October 8, 2013

Record last verified: 2018-03

Locations

US (1)