KCT0004912尚未招募未知
Prospective, Crossover, Randomized, Double-blind Study for the Compliance and Efficacy of Kynex and Kynex3 in Dry Eye Patients
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •? Adult males and females aged =19 years
- •? The diagnostic criteria at Visit 1 (Day 1) must include the following two characteristics:
- •? TBUT test result =10 seconds
- •? Subject’s assessment of dry eye condition (answers at least sometimes” to the question How often do you feel eye dryness enough that you want to use eye drops?”)
- •? Patients who are capable of understanding and signing an Informed Consent Form (ICF) approved by the Institutional Review Board (IRB)
- •? Those who are capable of understanding and voluntarily agree to this study
排除标准
- •? History of ocular or intraocular surgery on either eye within the last 6 months
- •? History of intolerance or hypersensitivity to any constituent of the study drugs
- •? In the presence of a history or evidence of herpes simplex virus epithelial keratitis; vaccination, active or recent corneal and/or conjunctival varicella virus disease. Ocular rosacea, a chronic bacterial disease of the cornea and/or conjunctiva and/or eyelid, mycobacterial ocular infection and/or ocular fungal disease
- •? Use of topical ophthalmic drugs during the study
- •? Subjects who are using a systemic medication which may induce dry eye (i.e., anti-common-cold and antiallergic drugs, tricyclic antidepressants, hormone replacement therapy) may not be allowed study entry if the dosage regimen has not been stable for at least 30 days prior to Visit 1. In addition, the dosage regimen should remain stable during the study.
- •? Eye conditions, such as active acute blepharitis, conjunctival inflammation, and iritis, or other eye conditions that may preclude safe administration of the study drug
- •? Those who wore contact lenses within 72 hours prior to screening or those who have to wear contact lenses or do not agree to not wearing contact lenses during the study
- •? Punctal occlusion (i.e., collagen plug, silicone plug) within 90 days prior to screening
- •? Vision correction surgery, such as laser-assisted in situ keratomileusis (LASIK), within 12 months prior to screening
- •? Autoimmune disease (e.g., Sjogren’s syndrome)
- •? Diagnosis of psychiatric disorder that may affect the conduct of this study
- •? History of drug or alcohol abuse
- •? An investigator or study staff, a family member of the investigator, a family member of the study staff , or an individual residing in the household of such persons
- •? Administration of other study drug or medical device within 30 days prior to study entry
研究者
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