Comparison of cyclosporin 0.05% versus cyclosporin 0.09% in moderate to severe dry eye disease - Nil

V Prasad Eye Institute0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年8月21日

试验速览

暂无简介。

•1.Written informed consent.
•2.Age more than 18 years at first visit
•3.Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logMAR
•4.Diagnosis of DED in both eyes supported by the criteria mentioned below
•Defined by at least one eye meeting all the following criteria:
•i. A symptom severity score of >=22 for OSDI
•ii.An unanesthetized Schirmer Tear Test (STT) score of >=1 mm and <=10 mm per 5 minutes or NIBUT <10seconds
•iii.Evidence of ocular surface staining (total fluorescein staining score of at least 3) [0-15 scale])
•5. Have normal lid anatomy and no other ocular disease except refractive errors or cataract
•If both eyes match the criteria, then eye with less Schirmer value would be chosen for statistical analysis

•1) Presence of corneal epithelial defects/infection
•2) Schirmer value of zero mm
•3) Any ocular surgery within past 3 months
•4) Any keratoplasty or ocular surface procedure performed during the trial
•5) Any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
•6) Have used RestasisÂ® (cyclosporine ophthalmic emulsion) or Cequa within 30 days prior to Visit 1.
•7) Clinically significant systemic disease (e.g., uncontrolled diabetes, hepatic, renal, endocrine or cardiovascular disorders)

发起方

V Prasad Eye Institute