CTRI/2024/05/068159尚未招募3 期
Safety profile and efficacy of Cyclisis PF, Preservative free Cyclosporine Ophthalmic Solution 0.05%, for treatment of Dry Eye Disease.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subjects between 18-75 years of age of both genders
- •2.Subjects with known case of dry eye disease
- •3.Best Corrected Visual Acuity (BCVA) of 6/24 [Log MAR equivalent (0.6)] or better
- •4.Ocular Surface Disease Index (OSDI) = 18
- •5.Tear film break-up time (TBUT) = 10 seconds
- •6.Schirmer tear test (without anesthesia) = 10mm / 5min
- •7.Tear Meniscus Height < 0.25mm
- •8.Corneal fluorescein staining score [as per National Eye Institute (NEI) scale] = 3
- •9.Conjunctival lissamine green staining score (as per NEI scale) =6
- •10.Normal lid position and closure
- •11.Willingness to sign written informed consent document
排除标准
- •1. Any ocular condition that, in the opinion of the Investigator, could affect study parameters. This includes, active ocular infection, ocular inflammation, ocular trauma, blepharitis or, any other condition as deemed by the Investigator.
- •2.Unwilling to refrain from contact lens use for the entire duration of this study.
- •3.Any significant illness that could interfere with study parameters.
- •4.History of any other ocular surgical procedure within 3 months.
- •5.Subject with known allergy or hypersensitivity to the components of the formulation.
研究者
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