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NCT00987467 · ClinicalTrials.gov registry record · NA
Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT00987467: Completed NA study, sponsored by Johns Hopkins University.
NCT00987467 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00987467, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study 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.
Interventions
- DRUG Cyclosporin 0.05% ophthalmic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00987467
The ClinicalTrials.gov registry entry for NCT00987467 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cyclosporin 0.05% ophthalmic is the first listed.
NCT00987467 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00987467 about?
NCT00987467 is a clinical study titled "Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis". 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 t...
What is the current status of trial NCT00987467?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2007-08. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00987467?
The interventions under investigation include: Cyclosporin 0.05% ophthalmic (DRUG).
Who is sponsoring clinical trial NCT00987467?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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