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OpenTrials
Completed

NCT Number: NCT00650338

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

To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in 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 2

Primary location

Sall Research Medical Center, 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.
  • Diagnosed with primary open-angle glaucoma or ocular hypertension.
  • 18 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-104 ophthalmic solution, low concentration

Drug

Topical ocular application

DE-104 ophthalmic solution, medium concentration

Drug

Topical ocular application

DE-104 ophthalmic solution, high concentration

Drug

Topical ocular application

Placebo

Drug

placebo

0.005% Latanoprost

Drug

Topical ocular application

Primary outcomes

  1. To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)

    Time frame: 28 days

Secondary outcomes

  1. To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.

    Time frame: 35 days

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Registry information

Official study title

A Randomized, Double-masked, Placebo- and Active- Controlled, Parallel-group, Multi-center, Dose-response Trial of DE-104 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 1, 2008
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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