A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 757
- 试验地点
- 1
- 主要终点
- Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease
研究概览
简要总结
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects with Dry Eye Disease
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)
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
- •18 years of age (either gender and any race);
- •Reported history of dry eye for at least 6 months prior to Visit 1;
- •History of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.
排除标准
- •Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- •Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
- •Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
- •Eye drop use within 2 hours of Visit 1;
- •Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- •Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;
- •Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
- •Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.
研究组 & 干预措施
Reproxalap (0.25%) for six weeks
Reproxalap four times daily (QID) for four weeks followed by two times daily (BID) for two weeks
干预措施: Reproxalap Ophthalmic Solution (0.25%) (Drug)
Vehicle for six weeks
Vehicle QID for four weeks followed by BID for two weeks
干预措施: Placebo Comparator (Drug)
Reproxalap (0.25%) for 12 months
Reproxalap (0.25%) QID for four weeks followed by BID for 11 months
干预措施: Reproxalap Ophthalmic Solution (0.25%) (Drug)
Vehicle for 12 months
Vehicle QID for four weeks followed by BID for 11 months
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease
时间窗: Safety assessment period (six weeks)
The proportion of 6-week safety population subjects that experience at least one visual acuity TE-SAE decrease (defined as an increase of 0.22 or greater in logMAR score) categorized as probably or definitely related to test article.
TE-SAEs of Increase in Intraocular Pressure
时间窗: Safety assessment period (12 months)
The proportion of 12-month safety population subjects that experience at least one intraocular pressure TE-SAE (increase from baseline of greater than or equal to 10 mmHg and intraocular pressure of greater than 25 mmHg) categorized as probably or definitely related to test article.
TE-SAEs of the Cornea
时间窗: Safety assessment period (12 months)
The proportion of 12-month safety population subjects that experience at least one cornea-related TE-SAE (detected via slit-lamp examination) categorized as probably or definitely related to test article.
TE-SAEs of the Retina
时间窗: Safety assessment period (12-months)
The proportion 12-month safety population subjects that experience at least one retinal TE-SAE(detected via fundoscopy) categorized as probably or definitely related to test article.
TE-SAEs of Visual Acuity Decrease
时间窗: Safety assessment period (12 months)
The proportion of 12-month safety population subjects that experience at least one visual acuity TE-SAE (defined as an increase of 0.22 or greater in logMAR score) categorized as probably or definitely related to test article.
次要结局
未报告次要终点