Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vernal Keratoconjunctivitis |
Drug: Cyclosporine A 0,05% eye drop Drug: ketotifen fumarate 0.025% eye drops |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
- To compare the number of relapses of ocular inflammation per year between cyclosporine and ketotifen treated groups. Relapses are defined as at least 100% increase of the sum of hyperemia, itching, Trantas dots and corneal involvement [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Differences of specific symptoms and signs, of TSyS, TSS, Quick questionnaire subscales and biochemical and [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- molecular parameters will be evaluated at baseline, after 1, 3 and 6 months of treatment and after 1 month of treatment discontinuation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | February 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
this group of patients is treated with the experimental drug (Cyclosporine A 0,05% eye drops) 2 times daily
|
Drug: Cyclosporine A 0,05% eye drop
Cyclosporine A 0.05% eye drops will be administered 2 times daily for six months in the first year of the study and in the second year of the study in a cross-over manner(from March to September)
Other Name: NOVA22007
|
| Active Comparator: 2 |
Drug: ketotifen fumarate 0.025% eye drops
ketotifen fumarate 0.025% eye drops 2 times daily for 6 months in the first year of the study (from March to September) and 6 months in the same period in the second year of the study in cross over manner.
Other Name: Zaditen collirio monodose
|
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 0.05% eye-drops in preventing VKC relapses compared to standard antiallergic (Ketotifen fumarate 0.025% eye-drops) treatment, and efficacy of Cyclosporine A 0.1% eye-drops in controlling acute phases compared to antiinflammatory (Desametasone 0.15% eye drops) treatments.
Eligibility| Ages Eligible for Study: | 5 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients affected by VKC will be enrolled by the three Centres involved in the project
- Diagnosis of VKC will be performed on the basis of personal and family history of systemic allergic diseases, clinical examination (presence of conjunctival tarsal and/or limbal papillae) and presence of eosinophils in the conjunctival scraping
Exclusion Criteria:
- Contact lens wearers
- Patients affected by other ocular diseases
- Patients subjected to ocular surgery in the preceding 6 months
- Patients under eye drop or systemic treatments for other diseases, or
- Patients enrolled in experimental trials in the preceding 6 months
Contacts and Locations| Italy | |
| University of Genova | |
| Genova, Italy | |
| University of Padua | |
| Padua, Italy | |
| University of Rome Campus Bio-Medico | |
| Rome, Italy, 00155 | |
| Principal Investigator: | alessandro lambiase, MD | University of Rome Campus Bio-Medico |
More Information
Publications:
| Responsible Party: | Alessandro Lambiase, University of Rome Campus Bio-Medico |
| ClinicalTrials.gov Identifier: | NCT00426023 History of Changes |
| Other Study ID Numbers: | eudract 2006-003689-32, FARM5YZTZW, ALMA1 |
| Study First Received: | January 23, 2007 |
| Last Updated: | January 27, 2009 |
| Health Authority: | Italy: Ethics Committee Italy: Agenzia Italiana del Farmaco- AIFA |
Keywords provided by Campus Bio-Medico University:
|
Vernal keratoconjunctivitis Cyclosporine Children Clinical trial |
Additional relevant MeSH terms:
|
Keratoconjunctivitis Conjunctivitis, Allergic Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Tetrahydrozoline Cyclosporins Cyclosporine Ketotifen Nasal Decongestants |
Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Antifungal Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013