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A 6-week Safety & Efficacy Study of Combination Intraocular Pressure-lowering Therapy in Patients With Open-angle Glaucoma or Ocular Hypertension

Primary Purpose

Glaucoma, Open-angle, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Combination IOP Lowering Therapy
Sponsored by
Alcon Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-angle focused on measuring Glaucoma, POAG, OAG, OHT

Eligibility Criteria

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

Adult patients of any race and either sex with open angle glaucoma or ocular hypertension.

Sites / Locations

  • Europe

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 3, 2003
Last Updated
April 12, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00051194
Brief Title
A 6-week Safety & Efficacy Study of Combination Intraocular Pressure-lowering Therapy in Patients With Open-angle Glaucoma or Ocular Hypertension
Official Title
A 6-week Safety and Efficacy Study of Combination IOP-lowering Therapy in Patients With Open-angle Glaucoma or Ocular Hypertension.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
July 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

5. Study Description

Brief Summary
To compare the intraocular pressure(IOP)-lowering efficacy of morning or evening instillations of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-angle, Ocular Hypertension
Keywords
Glaucoma, POAG, OAG, OHT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Combination IOP Lowering Therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Adult patients of any race and either sex with open angle glaucoma or ocular hypertension.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon Investigators
Organizational Affiliation
Alcon Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Europe
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A 6-week Safety & Efficacy Study of Combination Intraocular Pressure-lowering Therapy in Patients With Open-angle Glaucoma or Ocular Hypertension

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