CTRI/2021/02/031182尚未招募2 期
Topical human immunoglobulin as adjunct therapy in dry eye disease
Dr RP Centre of Ophthalmic Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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. IOP 5 to 22 mmHg in each eye
- •2. Tear film break up time (TFBUT) less than 7 seconds
- •3. Schirmers test less than 9 mm per 5min
- •4. Ocular Surface Disease Index (OSDI) score of at least 13.
排除标准
- •1. Patients not consenting to participate and follow-up, presence of active systemic or ocular infections (including HBV, HCV & HIV) at the time of initiation of therapy and history of recent ocular surgery in the preceding six weeks will not be included in the study.
- •2. Allergic to IVIG or any similar products, or excipients of IVIG eye drops 4 mg/ml.
- •3. Use of contact lenses within the last 2-weeks prior to the baseline Visit.
- •4. Pregnant or nursing/lactating
- •5. Current diagnosis of any of the following ocular conditions: Acute allergic conjunctivitis,Active infection (e.g. bacterial, viral, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids) , Active intraocular inflammation (e.g., retinitis, choroiditis, uveitis)
- •6. A cognitive or psychiatric deficit that precludes informed consent or ability to perform
- •7. Have active drug/alcohol dependence or abuse
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