A Randomized, Double-Masked, Parallel-Group, Vehicle Controlled, Multicenter, Exploratory Study Assessing the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom
研究概览
简要总结
The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.
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
- Double (Participant, Investigator)
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
- •Subjects who have a diagnosis of dry eye disease.
- •Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.
- •Subjects who are willing and able to refrain from using contact lenses during the study.
排除标准
- •Subjects with known hypersensitivity or contraindication to any component of the study medication.
- •Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter).
- •Subjects who are expected to require treatment with corticosteroids during the study.
- •Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit.
- •Subjects who have undergone any type of ocular surgery within three months prior to screening.
- •Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit.
- •Subjects with a history or presence of chronic generalized systemic or ocular disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
研究组 & 干预措施
0.3% BOL-303242-X ophthalmic suspension
0.3% BOL-303242-X ophthalmic suspension
干预措施: 0.3% BOL-303242-X ophthalmic suspension (Drug)
2% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension
干预措施: 2% BOL-303242-X ophthalmic suspension (Drug)
1% BOL-303242-X ophthalmic suspension
1% BOL-303242-X ophthalmic suspension
干预措施: 1% BOL-303242-X ophthalmic suspension (Drug)
2% BOL-303242-X ophthalmic suspension in the morning
2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)
干预措施: 2% BOL-303242-X ophthalmic suspension AM (Drug)
2% BOL-303242-X ophthalmic suspension PM
Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.
干预措施: 2% BOL-303242-X ophthalmic suspension PM (Drug)
结局指标
主要结局
Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom
时间窗: 12 weeks
Each symptom (ocular discomfort, dryness, grittiness, and stinging) was assessed to the nearest millimeter on a 0 - 10 cm Visual Analog Scale (VAS) by the subject. The worst VAS dry eye symptom was utilized in the analysis. The minimum for the worst symptom was 0 and the maximum for the worst symptom was 10.
Mean Corneal Staining Score
时间窗: 12 weeks
Total corneal staining score was calculated by adding the individual grades from 5 regions of the corneal surface (1: Central; 2: Superior; 3: Temporal; 4: Nasal; 5: Inferior). Grade 0 = none and Grade 3 = severe. The minimum total score possible was 0 and the maximum total score possible was 15. Higher scores indicated worse outcome.
次要结局
未报告次要终点