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Completed

NCT Number: NCT00868894

Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Artesia, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provided signed, written informed consent.
  • 18 years of age and older.
  • Diagnosed with primary open-angle glaucoma or ocular hypertension.
  • 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-104 medium concentration

Drug

Topical ocular application

DE-104 high concentration

Drug

Topical ocular application

Placebo

Drug

Topical ocular application

0.005% Latanoprost

Drug

Topical ocular application

Primary outcomes

  1. To compare the safety and efficacy of two concentrations of DE-104 ophthalmic solution with placebo and 0.005% latanoprost in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.

    Time frame: 15 days

Secondary outcomes

  1. To investigate the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Registry information

Official study title

A Randomized, Double-masked, Placebo- and Active-controlled, Multi-Center, Dose Escalation Trial of DE-104 Ophthalmic Solution in Japanese and Non-Japanese Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 25, 2009
Registry last updated
Nov 3, 2011

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.

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