Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426023
Status:
COMPLETED
Last Update Posted:
2009-01-28
First Post:
2007-01-23
Brief Title:
Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis
Sponsor:
Campus Bio-Medico University
Organization:
Campus Bio-Medico University
Study Overview
Official Title:
Multicenter Randomised Double Masked Controlled Studies on the Efficacy of Cyclosporine Eye Drop Treatment in Preventing Vernal Keratoconjunctivitis VKC Relapses and in Treating the Acute Phase
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This interventional study aims to evaluate the efficacy of Cyclosporine eye drop treatment in preventing relapses of Vernal Keratoconjunctivitis VKC and in treating the acute phases of the disease
Detailed Description:
Vernal keratoconjunctivitis VKC is a severe allergic disease characterised by chronic ocular surface inflammation with seasonal relapses Active phases of VKC require treatment with topical steroids to control inflammation and corneal damage that may lead to impairment of visual function and severe ocular discomfort To date safe and effective therapies in preventing relapses and controlling active phases of VKC are not available Few controlled trials have used topical Cyclosporine A CsA for the treatment of VKC The present multicenter double-masked randomised controlled clinical trial will allow to obtain further data on the safety and efficacy of topical treatment with Cyclosporine in patients affected by VKC Moreover this study will evaluate the efficacy of topical CsA in both preventing the relapses of VKC and controlling the active phases of the disease It is important to highlight that Cyclosporine eye drops are not currently commercially available in Italy and must be custom-made by specialized pharmacies As VKC mostly affects young patients it influences their daily life and their social interactions Moreover the severe signs and symptoms of the disease result in frequent ophthalmologic controls influencing school activities of children and working days for their parents with a relevant economic cost for the National Health System
Comparisons Efficacy of Cyclosporine A 005 eye-drops in preventing VKC relapses compared to standard antiallergic Ketotifen fumarate 0025 eye-drops treatment and efficacy of Cyclosporine A 01 eye-drops in controlling acute phases compared to antiinflammatory Desametasone 015 eye drops treatments
Comparisons Efficacy of Cyclosporine A 005 eye-drops in preventing VKC relapses compared to standard antiallergic Ketotifen fumarate 0025 eye-drops treatment and efficacy of Cyclosporine A 01 eye-drops in controlling acute phases compared to antiinflammatory Desametasone 015 eye drops treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ALMA1 | None | None | None |
| FARM5YZTZW | None | None | None |