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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410188
• Other study ID #: OPA-6566-101
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 27, 2011
• Last updated: February 7, 2014
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: February 2014
• Source: Acucela Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open-angle Glaucoma

Intervention

Drug:
• OPA-6566
OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
• Placebo
Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
• Latanoprost
Latanoprost (one drop once per day for 4 weeks)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Acucela Inc.	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Composite of Pharmacokinetics		28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28)	Yes
Secondary	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)	No