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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000006820 |
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Date of registration:
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02/12/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Neuroprotective efficacy of topical unoprostone isopropyl or nipradilol in patients with retinitis pigmentosa
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Scientific title:
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Neuroprotective efficacy of topical unoprostone isopropyl or nipradilol in patients with retinitis pigmentosa - Neuroprotective efficacy of topical unoprostone isopropyl or nipradilol in patients with retinitis pigmentosa |
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Date of first enrolment:
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2009/02/01 |
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Target sample size:
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50 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008065 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Address:
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Japan |
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Telephone:
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Email:
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Affiliation:
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Kyushu university hospital Department of Ophthalmology |
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Name:
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Tatsuro Ishibashi |
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Address:
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3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Japan |
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Telephone:
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Email:
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Affiliation:
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Kyushu university hospital Department of Ophthalmology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: (1) a past history of glaucoma or ocular hypertension (2) patients with another macular disorder, such as epiretinal membrane (3) a past history of using the test drug within 6 months (4) pregnant subjects, subjects suspected of being pregnant, or breast-feeding subjects (5) hypersensitivity to the test drug (6) a past history of the entry into another clinical trial within 1 year (7) inappropriate case judged by investigator or subinvestigators
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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retinitis pigmentosa
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Intervention(s)
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0.12% topical unoprostone isopropyl twice daily
0.25% topical nipradilol twice daily
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Primary Outcome(s)
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The efficacy of the treatment was monitored by the following parameters before and after treatment (6 months or 12 months). (1) best corrected visual acuity (2) visual field measurement testing using the Humphrey Field Analyzer (HFA: the central 10-2 Program) (3) retinal sensitivity measurement using microperimeter (MP-1) (4) retinal circulation measurement using Laser Speckle flowgrafy
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Source(s) of Monetary Support
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none
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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