Health Condition 1: null- Vernal KeratoConjuntivitis with Severe Keratitis
Conditions
Interventions
Intervention1: NOVA22007: Dose: 1mg/ml Ciclosporine
Frequency: 4 times a day
Route of administration: Instillation drops.
Total Duration - 12 months
Control Intervention1: Placebo: Dose: 0mg/ml Ciclos
Sponsors
NOVAGALI PHARMA SAS
Eligibility
Inclusion criteria
Inclusion criteria: 1.Documented informed consent form 2. Male or female patients from 4 to less than18 years of age. 3. Female of childbearing potential 4. History of at least one recurrence of VKC 5. Patients not receiving any treatment for an established and active VKC. 6. Active severe VKC 7.Mean score of 4 subjective symptoms photophobia, tearing,itching and mucous discharge) >= 60 mm using a 100 mm Visual Analogue Scale (where â??0â?? means no symptom and â??100â?? means the worst that have been ever experienced). 8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 9.Patient enrollment must occur early during the site VKC season in order to allow the 4 month treatment period during the site VKC season.
Exclusion criteria
Exclusion criteria: Ocular Conditions/Diseases: 1. Any relevant ocular anomaly . 2. Abnormal lid anatomy. 3. Active herpes keratitis. 4. History of ocular varicella-zoster. 5. Active ocular infection. 6. Any ocular diseases other than VKC requiring topical ocular treatment during the course of the study. Contact lenses wear. 7. Topical and/or systemic use of corticosteroids. 8. Topical ciclosporin (e.g. Restasis®), tacrolimus or sirolimus. 9. Scraping of the vernal plaque. 10. Ocular surgery within 6 months prior to the Baseline visit. 11. Disease not stabilized within 30 days before the Baseline Visit. 12. Presence or history of severe systemic allergy. 13. Any intake of systemic immunosuppressant drugs. 14. Known hypersensitivity to one of the components of medications. 15. History of malignancy. Compliance/Administrative 16.Pregnancy or lactation at the baseline Visit. 17. History of drug addiction or alcohol abuse. 18. Presence or history of any systemic or ocular disorder. 19. Patient not covered by a health insurance if required by the national legislation. 20. Participation in a clinical trial with an investigational substance within the past 30 days. 21. Participation in another clinical study at the same time as the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to compare the efficacy of two different dosing regimens of NOVA22007 versus placebo (vehicle of the formulation) on both the evolution of severe keratitis and the need for rescue medication.Timepoint: 4 months (Composite efficacy score at 4 months, defined as the mean of the efficacy scores taken at each monthly visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of the study are: To assess the safety and tolerability including ocular tolerance of 2 dosing regimens of NOVA22007 versus placebo. To assess the efficacy of 2 dosing regimens of NOVA22007 versus placebo on other signs and symptoms of VKC not covered in the primary objective.Timepoint: Months 1, 2, 3, 4, 6, 8, 10 & 12 | — |
Countries
France, Germany, Hungary, India, Israel, Italy, Portugal, Singapore, Spain, Turkey, United States of America
Contacts
Public ContactMr Sandeep Adsule
Chiltern International Pvt Ltd
Outcome results
None listed