NCT00804791已完成不适用
Residence Time Evaluation of Marketed OTC Ophthalmic Products
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Ocular Surface Residence Time
研究概览
简要总结
The objective of this study is to measure ocular surface residence time (in minutes) of two marketed OTC ophthalmic products in dry eye patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Informed consent and HIPAA read, signed and dated before conducting any procedures.
- •Adult volunteers diagnosed with mild to moderate dry eye. Criteria for diagnosis must include 2 of the 3 following characteristics: composite symptom score > or = to 5 on modified Schein questionnaire; NaFl TFBUT < or = to 7 seconds in either eye; or NaFl corneal staining sum score > or = to 3 (using 0-15 point grading system).
- •Able and willing to follow study instructions. 4) Best-corrected V.A. of 0.6 logMAR or better OU.
排除标准
- •History or evidence of ocular or intraocular surgery in either eye w/i the past 6 months.
- •History or evidence of serious ocular trauma in either eye w/i the past 6 months.
- •History of intolerance or hypersensitivity to any component of the study medications.
- •History or evidence of epithelial herpes simplex keratitis, vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva and/or eyelids, mycobacterial infection of the eye, and/or fungal disease of the eye.
- •Use of concomitant topical ocular medications during the study period.
- •Patients using systemic medications that may contribute to dry eye may not be enrolled unless they have been on a stable dosing regimen for a minimum of 30 days prior to Visit 1, and the dosing regimen must remain stable throughout the study period.
- •Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe admininstration of the test article.
- •Individuals unwilling to d/c contact lens wear during the study period. CL wear must have been d/c at least one week prior to Visit
- •Participation in an investigational drug or device study w/i 30 days of entering this study.
- •Additionally, any subject may be declared ineligible for a valid medical reason.
结局指标
主要结局
Ocular Surface Residence Time
时间窗: After 8 minutes, then every 2 minutes
Ocular surface residence time is the time for fluorescent intensity of the cornea to return to baseline measurement after installation of test article.
次要结局
未报告次要终点
研究者
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