A Phase 1/2 interventional study of OPA-6566 and Placebo in Primary Open-angle Glaucoma and Ocular Hypertension, sponsored by Kubota Vision Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-03-11.
Sponsored by Kubota Vision Inc. · Phase 1/2, Interventional, and Treatment
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 160 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Kubota Vision Inc. is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with OPA-6566 low dose
Drug: OPA-6566
Treatment with OPA-6566 medium dose
Drug: OPA-6566
Treatment with OPA-6566 high dose
Drug: OPA-6566
Treatment with Latanoprost
Drug: Latanoprost
Placebo
Drug: Placebo
Treatment with OPA-6566 additional dose
Drug: OPA-6566
OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
Latanoprost (one drop once per day for 4 weeks)
Safety: incidence of treatment emergent adverse events (TEAEs), vital signs, physical exam, ocular exams, electrocardiogram, ocular symptoms, laboratory tests on whole blood, serum and urine.
Time frame: 28 days of treatment: visit 1 (screening), visit 2 (eligibility), visit 3 (randomization) visit 4 (Day 14), visit 5 (Day 28)
Composite of Pharmacokinetics
Time frame: 28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28)
Efficacy: measurement of change in intraocular pressure from baseline.
Time frame: 28 days: visit 1 (screening); visit 2 (eligibility) ; visit 3 (randomization) , visit 4 (Day 14) ; visit 5 (Day 28)
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Kubota Vision Inc.