Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
1 other identifier
interventional
193
1 country
1
Brief Summary
The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with carteolol long-acting ophthalmic solution in subjects who are insufficiently responsive to carteolol long-acting ophthalmic solution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
November 17, 2015
CompletedDecember 28, 2015
November 1, 2015
9 months
March 27, 2014
October 15, 2015
November 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Decrease From Baseline in Intraocular Pressure at Week 8 Predose
Comparison of each group in change from baseline in intraocular pressure. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.
Baseline, Week 8 Predose
Secondary Outcomes (5)
Intraocular Pressure at Week 8 Predose
Week 8 Predose
Intraocular Pressure at Week 8 at 2 Hours After IMP Administration
Week 8 at 2 hours after IMP administration
Intraocular Pressure at Week 8 at 8 Hours After IMP Administration
Week 8 at 8 hours after IMP administration
Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration
Baseline, Week 8 at 2 hours after IMP administration
Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration
Baseline, Week 8 at 8 hours after IMP administration
Study Arms (2)
OPC-1085EL ophthalmic solution
EXPERIMENTALOnce daily
Carteolol long-acting ophthalmic solution
ACTIVE COMPARATOROnce daily
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension
You may not qualify if:
- Subjects with ocular conditions as defined by the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Kansai Region, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Deputy General Manager, Headquarters of Clinical Development
- Organization
- Otsuka Pharmaceutical Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2014
First Posted
April 7, 2014
Study Start
April 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
December 28, 2015
Results First Posted
November 17, 2015
Record last verified: 2015-11