Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Kubota Vision Inc.
Trial Summary
What is the purpose of this trial?This is a study of the safety, tolerability, pharmacokinetics (measurement of drug levels in the blood), and intraocular pressure lowering effects of OPA-6566 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension.
Eligibility Criteria
Inclusion Criteria
diagnosis of bilateral primary open-angle glaucoma
diagnosis of ocular hypertension as defined in the protocol
Participant Groups
6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: OPA-6566 medium doseExperimental Treatment1 Intervention
Treatment with OPA-6566 medium dose
Group II: OPA-6566 low doseExperimental Treatment1 Intervention
Treatment with OPA-6566 low dose
Group III: OPA-6566 high doseExperimental Treatment1 Intervention
Treatment with OPA-6566 high dose
Group IV: OPA-6566 additional doseExperimental Treatment1 Intervention
Treatment with OPA-6566 additional dose
Group V: LatanoprostActive Control1 Intervention
Treatment with Latanoprost
Group VI: PlaceboPlacebo Group1 Intervention
Placebo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT01410188Artesia, CA
NCT01410188Glendale, CA
NCT01410188Roswell, GA
NCT01410188Louisville, KY
More Trial Locations
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Who Is Running the Clinical Trial?
Kubota Vision Inc.Lead Sponsor
Otsuka Pharmaceutical Co., Ltd.Industry Sponsor