ong-term study on WP-1303 ophthalmic solution in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).

Wakamoto pharmaceutical Co., Ltd0 个研究点目标入组 360 人开始时间: 2018年12月3日最近更新: 2023年10月17日

适应症

试验速览

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•Each potential subject must satisfy all of the following criteria to be enrolled in the study.
•1)Patients with POAG, normal-tension glaucoma, exfoliation glaucoma, pigmentary glaucoma or OH
•2)Provision of written voluntary consent to participate in the study
•3)Japanease not less than 20 years of age at informed consent
•4)IOP at 9 o'clock of IOP confirmation date (-Day 14 to -Day 1) and IOP at 9 o'clock baseline (Day 0) should meet the following criteria:
•(1)IOP is less than 35 mmHg for both eyes
•(2)IOP at least one eye is not less than 15mmHg and the change from baseline IOP at IOP confirmation date is no more than 3 mmHg

•Any potential subject who meets any of the following criteria will be excluded from participating in the study.
•1)Patients who have visual acuity (corrected visual acuity if correction is necessary) of less than 0.3 in one eye at screening and baseline observation period.
•2)Presence of active eye disease (eg., uveitis, ocular infection, severe dry eye).
•3)Anticipated use of prohibited drugs between screening and at the completion of treatment phase.
•4)Anticipated wear of contact lenses in one eye between screening and at the completion of treatment phase.
•5)Presence of uncontrolled systemic disease (eg., hypertension, diabetes).

发起方