Efficacy and Safety of Topical Insulin on Ocular Surface Stability, Tear Film and Symptomatology in Patients with Dry Eye Disease and Diabetes Mellitus: A Randomized Controlled Clinical Trial

Dr R P Centre for Ophthalmic Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

研究概览

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•1.Type II Diabetic patients, >18 years of age, diagnosed with mild-moderate dry eye and consenting to participate in the study shall be enrolled.
•2. Dry eye shall be diagnosed based on Ocular Surface Disease Index (OSDI) score greater than 13, and TBUT < 10 seconds or Schirmer I score <10 mm.

•1.Patients with severe dry eye ; OSDI >33
•2. Schirmer I test less than 5 mm in either eye at screening.
•3.Patients with any uncontrolled severe systemic disease that may affect the eye (other than Diabetes Mellitus).
•4.Patients with use of any systemic medication that may affect tear film or vision within 3 months of screening .
•5.Any ocular/ophthalmic surgery or trauma, which could affect corneal sensitivity and/or tear distribution within 6 months prior to screening.
•6.Current or previous use of topical ocular medication within 2 weeks of screening and use of contact lens anticipated during the study or use 3 months prior to screening.
•7.Patients with raised intraocular pressure on screening and known cases of glaucoma shall also be excluded.

发起方

Dr R P Centre for Ophthalmic Sciences