DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%
Information source: Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Open Angle Glaucoma; Ocular Hypertension
Intervention: DE-111 ophthalmic solution (Drug); Tafluprost ophthalmic solution 0.0015% (Drug); Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5% (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Santen Pharmaceutical Co., Ltd.
Summary
DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost
0. 0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0. 0015%
and Timolol ophthalmic solution 0. 5% used concomitantly, 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.
Clinical Details
Official title: A Double-masked Study of DE-111 Ophthalmic Solution Versus Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension -Phase 3, Confirmatory Study-
Study design: Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Santen study sites, Osaka, Japan
Additional Information
Starting date: May 2011
Last updated: May 19, 2015
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