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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

Page last updated: August 23, 2015

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