Phase 3 Study Comparing IOP Lowering in OAG or OH in Japanese Subjects C-01-98

This study has been completed.

First Received on October 8, 2002. Last Updated on August 4, 2008 History of Changes

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00047593

Purpose

The purpose of this study is to evaluate safety and efficacy of two different IOP lowering medications after twelve months of treatment in Japanese subjects.

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	Drug: IOP Lowering Medications	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Phase 3 Study to Compare Two Different IOP Lowering Medications for the Treatment of Open Angle Glaucoma or Ocular Hypertension in Japanese Subjects C-01-98.

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

U.S. FDA Resources

Further study details as provided by Alcon Research:

Study Start Date:	January 2000
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Adults of Japanese Ethnicity

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047593

Locations

United States, California

Los Angeles, California, United States

San Francisco, California, United States
United States, Hawaii

Honolulu, Hawaii, United States

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00047593 History of Changes
Other Study ID Numbers:	C-01-98, C-01-98
Study First Received:	October 8, 2002
Last Updated:	August 4, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

open-angle
glaucoma
ocular
hypertension

POAG
Iris
Pigmentation
Japanese

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension

Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2012