MedDataX Logo

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

NCT ID: NCT01279083

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Open-angle Glaucoma Ocular Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Concentration 1

Group Type EXPERIMENTAL

DE-112

Intervention Type DRUG

Topical ocular solution

Concentration 2

Group Type EXPERIMENTAL

DE-112

Intervention Type DRUG

Topical ocular solution

Concentration 3

Group Type EXPERIMENTAL

DE-112

Intervention Type DRUG

Topical ocular solution

Concentration 4

Group Type EXPERIMENTAL

DE-112

Intervention Type DRUG

Topical ocular solution

Vehicle Solution

Group Type PLACEBO_COMPARATOR

DE-112 Vehicle Solution

Intervention Type DRUG

Topical ocular solution

Timolol Maleate Ophthalmic Solution

Group Type ACTIVE_COMPARATOR

Timolol Maleate Solution

Intervention Type DRUG

Topical ocular solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DE-112

Topical ocular solution

Intervention Type DRUG

DE-112

Topical ocular solution

Intervention Type DRUG

DE-112

Topical ocular solution

Intervention Type DRUG

DE-112

Topical ocular solution

Intervention Type DRUG

DE-112 Vehicle Solution

Topical ocular solution

Intervention Type DRUG

Timolol Maleate Solution

Topical ocular solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Santen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Austin, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

29-001

Identifier Type: -

Identifier Source: org_study_id