DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.

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Key information

Conditions

Open Angle Glaucoma or Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Santen study sites

Osaka, Japan

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed with 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.

Treatment and study plan

DE-111 ophthalmic solution

Drug

Primary outcomes

Change From Baseline in IOP (Intraocular Pressure) at End of Study

Time frame: Treatment period: Week 0 (Baseline) and Week 52 (End of Study)

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Long-term Open-label Study of DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension -Phase 3-

Important dates

Study start: 2011
Primary completion: 2013
First posted: Apr 27, 2011
Registry last updated: Jun 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed