Post Marketing, Single Arm, Observational Clinical Registry to Evaluate Safety and Efficacy of 0.5% Carboxymethylcellulose Eye Solution in real-world population with dry eye disease patients.

Amanta Healthcare Limited0 个研究点目标入组 315 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
•2.Patients having moderate to severe symptoms suggestive of dry eye wherein the study product would be prescribed by Investigator as part of standard of care.
•3.Patients who have been prescribed study product by Investigator as part of standard of care (SOC) practice and consent has been provided by patient post prescription of study product on the same day.

•Exclusion Criteria:
•1.Patients having any ocular diseases (corneal abrasion, ocular infection, foreign body trapping or ocular trauma), present or past, other than dry eye
•2.History of ocular surgery. History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time
•3.Patients using contact lens or topic treatments other than tear substitutes
•4.History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months
•5.History or active signs of ocular allergic disease or ocular herpes within the last year
•6.Patients participating in any another clinical trial during study
•7.Pregnant/lactating women during study period.

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