DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%

Last updated: May 19, 2015
Sponsor: Santen Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Stress

Glaucoma

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT01342081
01111004
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 reliablecontraceptive throughout the study, and must have a negative urine pregnancy testprior to enrollment into this study.

Exclusion

Exclusion Criteria:

  • Females who are pregnant, nursing or planning a pregnancy, or females of childbearingpotential who are not using a reliable method of contraception.

  • Presence of any abnormality or significant illness that could be expected to interferewith the study.

Study Design

Total Participants: 489
Study Start date:
May 01, 2011
Estimated Completion Date:

Connect with a study center

  • Santen study sites

    Osaka,
    Japan

    Site Not Available

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