A Multicentric, Randomized, Double Blind, Parallel Group,Comparative, Active Controlled, Phase-III Clinical Study to Evaluatethe Efficacy, Safety and Tolerability of Fixed Dose Combination(FDC) of Ripasudil 0.4% w/v + Timolol 0.5% w/v Eye Drops versusRipasudil Eye Drops 0.4% w/v and Timolol Eye Drops 0.5% w/vmonotherapy in treatment of elevated intraocular pressure (IOP) insubjects with open angle glaucoma or ocular hypertension

Ajanta Pharma Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•Newly diagnosed Male or female subjects aged greater than equal 18 and less than equal 65 years with primary open angle glaucoma or ocular hypertension in at least one eye confirmed by Goldmann applanation tonometry
•Subjects with IOP between 22 mmHg to 36 mmHg at the time of screening in any one eye In case both the eyes of a single subject are affected then the eye fulfilling the criteria will be considered for the evaluations If both eyes are fulfilling the criteria then the right eye will be considered for the study
•Best corrected visual acuity 6 by 60 or better
•Subjects with ability to understand and provide written informed consent form which must have been obtained prior to screening
•Subjects willing to comply with the protocol requirements

•Subjects with known hypersensitivity to any of the components of the formulation
•Has clinical laboratory evaluations including biochemistry and hematology are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator
•Subjects with known case of any severe or advanced cases of Glaucoma IOP greater than 36 mmHg in either eye
•Shaffer angle grade less than 2 in either eye range 0 complete or partial closure to 3 wide open angle greater than 20 as measured by Gonioscopy
•Subjects who are blind or subjects who have a single eye
•Severe central visual field loss in either eye measured by Perimetry
•Subjects having central corneal thickness greater than 620 Ã?Âµm in either eye as measured by Pachymetry
•Cupdisc ratio greater than 0.80
•Subject who are schedule to undergo surgery of the eye during the study period

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