Skip to main content
OpenTrials
Completed

NCT Number: NCT01279083

Safety and Efficacy Trial to Treat Open-Angle Glaucoma or Ocular Hypertension

To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.

Completed

Looking for future studies?

Notify Me

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

Austin, Texas, United States

Loading trial locations.

About this study

This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects.

Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provide signed, written informed consent
  • 18 yeas of age and older
  • Diagnosed with primary open-angle glaucoma or ocular hypertension
  • Female subject of childbearing potential must utilize reliable contraceptive throughout the study and have a negative urine pregnancy test prior to enrollment into this study
  • Meet specific Visit 2, Day 0 (Baseline)criteria at baseline

Exclusion criteria

  • Females who are pregnant, nursing or planning a pregnancy
  • Presence of any abnormality or significant illness that could be expected to interfere with the study.

Treatment and study plan

DE-112

Drug

Topical ocular solution

DE-112 Vehicle Solution

Drug

Topical ocular solution

Timolol Maleate Solution

Drug

Topical ocular solution

Primary outcomes

  1. Intraocular pressure (IOP)

    Time frame: 29 days

    Change from baseline in mean diurnal IOP

Secondary outcomes

  1. Intraocular pressure (IOP)

    Time frame: 29 days

    Percent change from baseline in mean diurnal IOP

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Registry information

Official study title

A Phase I/II Dose Escalation Safety and Efficacy Trial of DE-112 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jan 19, 2011
Registry last updated
Dec 17, 2012

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.

Related clinical trials

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