Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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An Investigator-Masked, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

Conditions
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Primary Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: OPA-6566
* Drug: Placebo
* Drug: Latanoprost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of bilateral primary open-angle glaucoma diagnosis of ocular hypertension as defined in the protocol Exclusion Criteria: any form of glaucoma other than primary open-angle glaucoma in either eye other ocular conditions as defined by the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPA-6566 low dose<br>Treatment with OPA-6566 low dose | Drug: OPA-6566<br>* OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)<br>|
| Experimental: OPA-6566 medium dose<br>Treatment with OPA-6566 medium dose | Drug: OPA-6566<br>* OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)<br>|
| Experimental: OPA-6566 high dose<br>Treatment with OPA-6566 high dose | Drug: OPA-6566<br>* OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)<br>|
| Active Comparator: Latanoprost<br>Treatment with Latanoprost | Drug: Latanoprost<br>* Latanoprost (one drop once per day for 4 weeks)<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)<br>|
| Experimental: OPA-6566 additional dose<br>Treatment with OPA-6566 additional dose | Drug: OPA-6566<br>* OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 28 days of treatment: visit 1 (screening), visit 2 (eligibility), visit 3 (randomization) visit 4 (Day 14), visit 5 (Day 28) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Pharmacokinetics |  | 28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28) | 
| Efficacy: measurement of change in intraocular pressure from baseline. |  | 28 days: visit 1 (screening); visit 2 (eligibility) ; visit 3 (randomization) , visit 4 (Day 14) ; visit 5 (Day 28) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open-angle glaucoma, glaucoma, ocular hypertension, intraocular pressure