Back to resultsDE-111 Against Timolol Ophthalmic Solution 0.5%
Primary Purpose
Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
DE-111 ophthalmic solution
Timolol ophthalmic solution 0.5%
Placebo ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Primary open angle glaucoma or ocular hypertension
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with primary open angle glaucoma or ocular hypertension
- Provided signed, written informed consent
- 20 years of age and older
- If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study
Exclusion Criteria:
- Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
- Presence of any abnormality or significant illness that could be expected to interfere with the study
Sites / Locations
- Santen study sites
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DE-111 ophthalmic solution
Timolol ophthalmic solution 0.5%
Arm Description
DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
Outcomes
Primary Outcome Measures
Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study
Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.
Secondary Outcome Measures
Full Information
NCT ID
NCT01342094
First Posted
April 24, 2011
Last Updated
June 14, 2015
Sponsor
Santen Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01342094
Brief Title
DE-111 Against Timolol Ophthalmic Solution 0.5%
Official Title
A Double-masked Study of DE-111 Ophthalmic Solution Versus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension - Phase 3, Confirmatory Study -
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
Keywords
Primary open angle glaucoma or ocular hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DE-111 ophthalmic solution
Arm Type
Experimental
Arm Description
DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
Arm Title
Timolol ophthalmic solution 0.5%
Arm Type
Active Comparator
Arm Description
Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
Intervention Type
Drug
Intervention Name(s)
DE-111 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Timolol ophthalmic solution 0.5%
Intervention Type
Drug
Intervention Name(s)
Placebo ophthalmic solution
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study
Description
Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.
Time Frame
Week 0(Baseline) and Week 4(End of Study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Eligibility Criteria
Inclusion Criteria:
Diagnosed with primary open angle glaucoma or ocular hypertension
Provided signed, written informed consent
20 years of age and older
If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study
Exclusion Criteria:
Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
Presence of any abnormality or significant illness that could be expected to interfere with the study
Facility Information:
Facility Name
Santen study sites
City
Osaka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
DE-111 Against Timolol Ophthalmic Solution 0.5%
We'll reach out to this number within 24 hrs