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A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brinzolamide/Timolol
Sponsored by
Alcon Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma

Eligibility Criteria

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

Inclusion Criteria: Adults of either sex and any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) Exclusion Criteria: Under 18

Sites / Locations

  • Fort Worth and Other Sites

Outcomes

Primary Outcome Measures

Ocular discomfort

Secondary Outcome Measures

Full Information

First Posted
May 12, 2006
Last Updated
November 17, 2016
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00326092
Brief Title
A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Official Title
A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the comfort of a glaucoma 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
Open-angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
88 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Brinzolamide/Timolol
Primary Outcome Measure Information:
Title
Ocular discomfort

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults of either sex and any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) Exclusion Criteria: Under 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia White
Organizational Affiliation
Study Director
Official's Role
Study Director
Facility Information:
Facility Name
Fort Worth and Other Sites
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19049301
Citation
Vold SD, Evans RM, Stewart RH, Walters T, Mallick S. A one-week comfort study of BID-dosed brinzolamide 1%/timolol 0.5% ophthalmic suspension fixed combination compared to BID-dosed dorzolamide 2%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2008 Dec;24(6):601-5. doi: 10.1089/jop.2008.0030.
Results Reference
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A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

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