NCT01736527已完成1 期
Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% at 6, 9, 12, and 24 Hours Following a Single Instillation in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Tear Fluid Levels
研究概览
简要总结
To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be healthy volunteers with physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- •Subjects must have a best-corrected visual acuity of 20/20 or better in each eye.
- •Subjects must have no active ocular disease or allergic conjunctivitis.
- •Subjects must have a Schirmer test (without anesthesia) of ≥ 10mm in 5 minutes.
- •Subjects must not be using any topical ocular medications or systemic medication other than acetaminophen.
- •Male subjects or female subjects who are not of childbearing potential. Female subjects are considered to not be of childbearing potential if they are postmenopausal for at least 12 months or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)
排除标准
- •Subjects having an intraocular pressure less than 5 mmHg or greater than 22 mmHg or any type of glaucoma.
- •Subjects with a history of ocular trauma, infection, or inflammation within the last 3 months.
- •Subjects having any contraindication to the use of, or known sensitivity or allergy to, the study drug(s) or their components.
- •Subjects wearing contact lenses on the day of Visit 2 and/or Visit 3 of the study
- •Subjects having, at the Investigator's discretion, the presence of any significant illness that could be expected to interfere with the study.
研究组 & 干预措施
LE Gel
Experimental
A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.
干预措施: LE Gel (Drug)
结局指标
主要结局
Tear Fluid Levels
时间窗: 24 hours
Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract SurgeryOcular InflammationNCT00699153Bausch & Lomb Incorporated400
已完成
3 期
Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract SurgeryInflammationPainCataractNCT01996839Bausch & Lomb Incorporated514
已完成
3 期
Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract SurgeryInflammationPainCataractNCT02208297Bausch & Lomb Incorporated326
已完成
2 期
Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen ChallengeAllergic ConjunctivitisNCT01107405Bausch & Lomb Incorporated101
已完成
4 期
Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant RejectionCorneal Endothelial DystrophyCorneal EdemaNCT05136443Price Vision Group70