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| ID | Type | Description | Link |
|---|---|---|---|
| FARM5YZTZW | |||
| ALMA1 |
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| Name | Class |
|---|---|
| University of Genova | OTHER |
| University of Padova | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | this group of patients is treated with the experimental drug (Cyclosporine A 0,05% eye drops) 2 times daily |
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| 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine A 0,05% eye drop | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Differences of specific symptoms and signs, of TSyS, TSS, Quick questionnaire subscales and biochemical and | 2 years | |
| molecular parameters will be evaluated at baseline, after 1, 3 and 6 months of treatment and after 1 month of treatment discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| alessandro lambiase, MD | University of Rome Campus Bio-Medico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rome Campus Bio-Medico | Rome | Rome | 00155 | Italy | ||
| University of Genova |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10857837 | Background | Bonini S, Bonini S, Lambiase A, Marchi S, Pasqualetti P, Zuccaro O, Rama P, Magrini L, Juhas T, Bucci MG. Vernal keratoconjunctivitis revisited: a case series of 195 patients with long-term followup. Ophthalmology. 2000 Jun;107(6):1157-63. doi: 10.1016/s0161-6420(00)00092-0. | |
| 14501439 | Background | Bonini S, Lambiase A, Sgrulletta R, Bonini S. Allergic chronic inflammation of the ocular surface in vernal keratoconjunctivitis. Curr Opin Allergy Clin Immunol. 2003 Oct;3(5):381-7. doi: 10.1097/00130832-200310000-00011. |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D007665 | Ketotifen |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
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| ketotifen fumarate 0.025% eye drops | Drug | 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. |
|
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| 2 years |
| Genova |
| Italy |
| University of Padua | Padua | Italy |
| 1337745 | Background | Bonini S, Barney NP, Schiavone M, Centofanti M, Berruto A, Bonini S, Allansmith MR. Effectiveness of nedocromil sodium 2% eyedrops on clinical symptoms and tear fluid cytology of patients with vernal conjunctivitis. Eye (Lond). 1992;6 ( Pt 6):648-52. doi: 10.1038/eye.1992.139. |
| 16023216 | Background | Bonini S, Micera A, Iovieno A, Lambiase A, Bonini S. Expression of Toll-like receptors in healthy and allergic conjunctiva. Ophthalmology. 2005 Sep;112(9):1528; discussion 1548-9. doi: 10.1016/j.ophtha.2005.04.009. |
| 9246280 | Background | Mendicute J, Aranzasti C, Eder F, Ostolaza JI, Salaberria M. Topical cyclosporin A 2% in the treatment of vernal keratoconjunctivitis. Eye (Lond). 1997;11 ( Pt 1):75-8. doi: 10.1038/eye.1997.14. |
| 2248328 | Background | Secchi AG, Tognon MS, Leonardi A. Topical use of cyclosporine in the treatment of vernal keratoconjunctivitis. Am J Ophthalmol. 1990 Dec 15;110(6):641-5. doi: 10.1016/s0002-9394(14)77061-8. |
| 11318292 | Background | Gupta V, Sahu PK. Topical cyclosporin A in the management of vernal keratoconjunctivitis. Eye (Lond). 2001 Feb;15(Pt 1):39-41. doi: 10.1038/eye.2001.10. |
| 3953723 | Background | BenEzra D, Pe'er J, Brodsky M, Cohen E. Cyclosporine eyedrops for the treatment of severe vernal keratoconjunctivitis. Am J Ophthalmol. 1986 Mar 15;101(3):278-82. doi: 10.1016/0002-9394(86)90819-6. |
| 12052387 | Background | Leonardi A. Vernal keratoconjunctivitis: pathogenesis and treatment. Prog Retin Eye Res. 2002 May;21(3):319-39. doi: 10.1016/s1350-9462(02)00006-x. |
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |