MedDataX Logo

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

NCT ID: NCT00868894

Last Updated: 2011-11-03

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

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-06-30

Brief Summary

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

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.

Detailed Description

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

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.

1

Group Type EXPERIMENTAL

DE-104 medium concentration

Intervention Type DRUG

Topical ocular application

2

Group Type EXPERIMENTAL

DE-104 high concentration

Intervention Type DRUG

Topical ocular application

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Topical ocular application

4

Group Type ACTIVE_COMPARATOR

0.005% latanoprost

Intervention Type DRUG

Topical ocular application

Interventions

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

DE-104 medium concentration

Topical ocular application

Intervention Type DRUG

DE-104 high concentration

Topical ocular application

Intervention Type DRUG

Placebo

Topical ocular application

Intervention Type DRUG

0.005% latanoprost

Topical ocular application

Intervention Type DRUG

Eligibility Criteria

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

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.
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.

Artesia, California, United States

Site Status

Pasadena, California, United States

Site Status

San Francisco, California, United States

Site Status

Honolulu, Hawaii, United States

Site Status

Kailua, Hawaii, United States

Site Status

New York, New York, 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.

27-003

Identifier Type: -

Identifier Source: org_study_id