Timolol maleate 0.5% and dorzolamide/timolol maleate fixed combination and latanoprost 0.005% in Ocular Hypertension and Open-Angle Glaucoma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Florida
  - Lakeland, Florida, United States, 33805
    - Central Florida Eye Associates
- Illinois
  - Bourbonnais, Illinois, United States, 60914
    - Midwest Eye Center SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

adults with primary open-angle, pigmentary, or exfoliation glaucoma, or ocular hypertenstion
intraocular pressure should be 22 to 30 mm Hg inclusive on timolol BID at the 08:00 H
ETDRS visual acuity must be 1.0 or better in both eyes

Exclusion Criteria:

any contraindications to study medications
any anticipated change in systemic hypertensive therapy during the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmaceutical Research Network

Investigators

Study Director: William C. Stewart, MD, Pharmaceutical Research Network, LLC
Principal Investigator: Jay Mulaney, MD, Central Florida Eye Associates
Principal Investigator: Sriram Sonty, MD, FACS, Midwest Eye Center SC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

January 6, 2006

First Submitted That Met QC Criteria