A Multicenter, Randomized double masked, 3 parallel arms, placebo controlled study to assess the efficacy and safety of NOVA22007 1Mg/Ml (ciclosporin/ cyclosporine) eye drops, emulsion administered in paediatric patients with active severe Vernal Keratoconjunctivitis with severe keratitis.

OVAGALI PHARMA SAS0 个研究点目标入组 168 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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.

•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. RestasisÂ®), 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.

发起方

OVAGALI PHARMA SAS