WP-1303 Phase III long-term study
- Conditions
- Japanease patients with POAG, normal-tension glaucoma, exfoliation glaucoma, pigmentary glaucoma or OH
- Registration Number
- JPRN-jRCT2080224167
- Lead Sponsor
- Wakamoto pharmaceutical Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 360
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy:intraocular pressure<br>safety:adverse event and adverse drug reaction
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>efficacy:intraocular pressure<br>safety:adverse event and adverse drug reaction