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

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.
ClinicalTrials.gov Identifier:
NCT01410188
First received: July 27, 2011
Last updated: February 7, 2014
Last verified: February 2014

July 27, 2011
February 7, 2014
September 2011
October 2012   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01410188 on ClinicalTrials.gov Archive Site
  • Composite of Pharmacokinetics [ Time Frame: 28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Primary Open-angle Glaucoma
  • Ocular Hypertension
  • Drug: OPA-6566
    OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
  • Drug: Placebo
    Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
  • Drug: Latanoprost
    Latanoprost (one drop once per day for 4 weeks)
  • Experimental: OPA-6566 low dose
    Treatment with OPA-6566 low dose
    Intervention: Drug: OPA-6566
  • Experimental: OPA-6566 medium dose
    Treatment with OPA-6566 medium dose
    Intervention: Drug: OPA-6566
  • Experimental: OPA-6566 high dose
    Treatment with OPA-6566 high dose
    Intervention: Drug: OPA-6566
  • Active Comparator: Latanoprost
    Treatment with Latanoprost
    Intervention: Drug: Latanoprost
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: OPA-6566 additional dose
    Treatment with OPA-6566 additional dose
    Intervention: Drug: OPA-6566
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01410188
OPA-6566-101
Yes
Acucela Inc.
Acucela Inc.
Otsuka Pharmaceutical Co., Ltd.
Study Director: John W Chandler, MD Acucela Inc.
Acucela Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP