Assessment of the Anti-inflammatory Effects of Norflo Oro in Acute Relapses of HLA-B27 Associated Autoimmune Uveitis: a Multicenter Randomized, Placebo Controlled, Double-blind Clinical Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Eye Pharma
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline
研究概览
简要总结
The purpose of this study is to explore the efficacy of Norflo Oro in the treatment of relapsing autoimmune uveitis (RAU), measured as a long term reduction of the frequency and the severity of relapses, in patients with HLA-B27 associated uveitis, under conditions of routine medical practice. The reduction of the mean number of relapses per patient between the year before study treatment and the study period will also be assessed.
详细描述
The secondary objective of this study will be: (i) evaluation of the improvement of side effects due to HLA-B27 associated uveitis such as intraocular pressure (IOP), cystoid macular edema, keratophaty and synechia (ii) evaluation of the improvement in uveitis-related symptoms: BCVA and symptoms measured by VAS, like ocular pain, photophobia, floaters and blurred vision; (iii) evaluation of cell damage and inflammation reduction in patients with HLA-B27 associated uveitis; (iv) evaluation of the patients' attitude towards the study treatment and also the evaluation of the safety profile of the study product.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Up to 60 eligible patients will be randomly assigned to NORFLO® ORO or placebo treatment groups in a 1:1 ratio using a stratified randomization blocks scheme.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of HLA-B27 positive related uveitis in non- acute phase
- •At least one autoimmune uveitis relapse
排除标准
- •Use of supplements (nutraceuticals) or systemic therapy for uveitis with anti-inflammatory immunosuppressive or biological drugs within last 30 days
- •Anticipated need for systemic anti-inflammatory treatment during the study
- •Use of intravitreal peribulbar, sub-tenon, periocular injection in the previous 6 months
- •Long-term treatment with a systemic anti-inflammatory, immune suppressant drugs
- •Woman taking hormonal contraceptives, pregnant or breastfeeding.
研究组 & 干预措施
Norflo Oro
The study subject will take the entire content of one packet of Norflo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.
干预措施: Norflo Oro (Drug)
Placebo for Norflo Oro
The study subject will take the entire content of one packet of Placebo (each box contains 30 packets) with meal twice per day for one year. The study subject will be evaluated in a total of three visits.
干预措施: Placebo for Norflo Oro (Drug)
结局指标
主要结局
Change in Mean Number of Uveitis Relapses Per Patient Between the 12 Month Study Period Compared to Baseline
时间窗: Baseline and 12 months
The mean number of uveitis relapses per patient in the 12 months of study duration (12 months) will be compared to the average number of uveitis relapses per patient in the 12 months before (baseline) for the Norflo Oro group and for the Placebo group.
次要结局
- Changes in Side Effects Associated With HLA-B27 Uveitis(12 months)