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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 12
- 主要终点
- 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.
研究概览
简要总结
This study is 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. The study will be conducted in 11 countries recruiting 168 patients globally. In India the study will be conducted in 8 sites. The primary objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe VKC after 4 months of treatment. The secondary objectives are to assess the safety and the tolerability including ocular tolerance of 2 dosing regimens of NOVA22007 versus placebo and to assess the efficacy of the 2 dosing regimens of NOVA22007 versus placebo on other signs and symptoms of VKC not covered in the primary objective. The first patient recruitment is being expected in June 2014.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Documented informed consent form
- •Male or female patients from 4 to less than18 years of age.
- •Female of childbearing potential
- •History of at least one recurrence of VKC
- •Patients not receiving any treatment for an established and active VKC.
- •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 “0†means no symptom and “100†means the worst that have been ever experienced).
- •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.
排除标准
- •Ocular Conditions/Diseases:
- •Any relevant ocular anomaly .
- •Abnormal lid anatomy.
- •Active herpes keratitis.
- •History of ocular varicella-zoster.
- •Active ocular infection.
- •Any ocular diseases other than VKC requiring topical ocular treatment during the course of the study.
- •Contact lenses wear.
- •Topical and/or systemic use of corticosteroids.
- •Topical ciclosporin (e.g. Restasis®), tacrolimus or sirolimus.
- •Scraping of the vernal plaque.
- •Ocular surgery within 6 months prior to the Baseline visit.
- •Disease not stabilized within 30 days before the Baseline Visit.
- •Presence or history of severe systemic allergy.
- •Known hypersensitivity to one of the components of medications.
- •History of malignancy.
- •Compliance/Administrative 16.Pregnancy or lactation at the baseline Visit.
- •History of drug addiction or alcohol abuse.
- •Presence or history of any systemic or ocular disorder.
- •Patient not covered by a health insurance if required by the national legislation.
- •Participation in a clinical trial with an investigational substance within the past 30 days.
- •Participation in another clinical study at the same time as the present study.
结局指标
主要结局
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.
时间窗: 4 months (Composite efficacy score at 4 months, defined as the mean of the efficacy scores taken at each monthly visit.
次要结局
- The secondary objectives of the study are:(To assess the safety and tolerability including ocular tolerance of 2 dosing regimens of NOVA22007 versus placebo.)