Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 176
- 主要终点
- Percentage of Treatment Responders
研究概览
简要总结
This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 months of the study, patients will receive either masked Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients who are in remission, will be re-randomized to receive either open-labeled Cyclosporine 0.010% eye drops four times daily or twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a clinical diagnosis of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye)
- •Be on stable doses of your current AKC medications for at least 2 weeks
排除标准
- •You have used contact lenses within 48 hours of Day 1 or think you may have to wear contact lenses during the study
- •You are pregnant, breastfeeding, or planning to become pregnant during the study
- •You have used a calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) on or around your eyes including eyelids within 4 weeks
研究组 & 干预措施
Cyclosporine Ophthalmic Solution (COS) followed by COS
Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
干预措施: Cyclosporine 0.010% (Drug)
Placebo followed by COS
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
干预措施: Cyclosporine Vehicle (Drug)
Placebo followed by COS
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
干预措施: Cyclosporine 0.010% (Drug)
结局指标
主要结局
Percentage of Treatment Responders
时间窗: Baseline, Month 2
Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is \>316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe).
次要结局
- Percentage of Punctate Corneal Staining Responders(Month 2)
- Percentage of Patients With an Improvement in the Composite Symptom Score(Baseline, Month 2)
- Percentage of Patients With an Improvement in the Punctate Corneal Staining Score(Baseline, Month 2)