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Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Glaucoma therapy
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

Eligibility Criteria

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

Inclusion Criteria: Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; logMAR visual acuity not worse than 0.6. Exclusion Criteria: Clinically relevant ophthalmic or systemic conditions may be excluded.

Sites / Locations

  • Alcon Clinical Trial Sites

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 30, 2003
Last Updated
August 4, 2008
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00069719
Brief Title
Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients
Official Title
Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

5. Study Description

Brief Summary
To determine the safety and IOP-lowering ability of a test compound 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
Keywords
open-angle, glaucoma, ocular, hypertension, POAG

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)
Glaucoma therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; logMAR visual acuity not worse than 0.6. Exclusion Criteria: Clinically relevant ophthalmic or systemic conditions may be excluded.
Facility Information:
Facility Name
Alcon Clinical Trial Sites
City
Multiple Locations Throughout the US Sponsored by Alcon of
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

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