Masked, Placebo Controlled, Phase I Trial to Assess the Safety of Bosentan 5 mg/ml Ophthalmic Eyewash in Type II Diabetic Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Retinset SL
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Epitheliopathy
研究概览
简要总结
This study evaluates the safety of topical Bosentan in Type II Diabetes patients
详细描述
The study is a Phase I, masked, placebo controlled clinical trial to assess safety of topical Bosentan in Type II Diabetes patients with no diabetes retinopathy
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
Placebo and Study Drug have the same physical characteristics, labeling and packaging
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent;
- •Type II Diabetes Mellitus;
- •18 or more years old
排除标准
- •Pregnant or breastfeeding Women
- •Known allergy or intolerance to investigational product or any of its excipients
- •Severe corneal abnormalities
- •Any relevant ocular / ophthalmic pathology that may put study results at risk in the opinion of Principal Investigator
- •Any sign or symptom of Diabetes Retinopathy
- •Any ocular surgery in the 6 previous months to study inclusion
- •Uncontrolled diabetes in the previous 3 months to inclusion or HbA1c levels ≥ 9% at baseline.
- •Oxford Scale or OSDI scores compatible with study failure at inclusion visit. (Oxford ≥ 5 or OSTDI ≥ 13)
- •Previous hepatopathy history or signs of hepatopathy at baseline.
- •Contact lens use
- •Actual treatment with the commercially available presentation
研究组 & 干预措施
Treatment
The patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized
干预措施: Bosentan (Drug)
Placebo
The patient will receive investigational product in one eye and placebo in the other eye. The allocation of treatment / placebo is masked and randomized
干预措施: Placebo (Drug)
结局指标
主要结局
Epitheliopathy
时间窗: 1 month
Presence of epitheliopathy in the cornea or conjunctiva
次要结局
- Presence of ocular discomfort(1 month)
- Anterior segment inflammation(1 month)