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

December 14, 2012 updated by: Santen Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78731
      • San Antonio, Texas, United States, 78207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle Solution
Drug: DE-112 Vehicle Solution
Topical ocular solution
Experimental: Concentration 1
Drug: DE-112
Topical ocular solution
Experimental: Concentration 2
Drug: DE-112
Topical ocular solution
Experimental: Concentration 3
Drug: DE-112
Topical ocular solution
Experimental: Concentration 4
Drug: DE-112
Topical ocular solution
Active Comparator: Timolol Maleate Ophthalmic Solution
Drug: Timolol Maleate Solution
Topical ocular solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure (IOP)
Time Frame: 29 days
Change from baseline in mean diurnal IOP
29 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure (IOP)
Time Frame: 29 days
Percent change from baseline in mean diurnal IOP
29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 18, 2011

First Posted (Estimate)

January 19, 2011

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 14, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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