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

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IOP Lowering Medications
Sponsored by
Alcon Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring open-angle, glaucoma, ocular, hypertension, POAG, Iris, Pigmentation, Japanese

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Adults of Japanese Ethnicity

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 8, 2002
Last Updated
August 4, 2008
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00047593
Brief Title
Phase 3 Study Comparing IOP Lowering in OAG or OH in Japanese Subjects C-01-98
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension
Keywords
open-angle, glaucoma, ocular, hypertension, POAG, Iris, Pigmentation, Japanese

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
IOP Lowering Medications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Adults of Japanese Ethnicity
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Honolulu
State/Province
Hawaii
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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