NCT00273429

Brief Summary

To compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once daily.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
Last Updated

January 9, 2007

Status Verified

January 1, 2007

First QC Date

January 6, 2006

Last Update Submit

January 8, 2007

Conditions

Open-Angle GlaucomaOcular Hypertension

Interventions

timolol maleate 0.5%DRUG
dorzolamide/timolol maleate fixed combinationDRUG
latanoprost 0.005%DRUG
placeboDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Florida Eye Associates

Lakeland, Florida, 33805, United States

Location

Midwest Eye Center SC

Bourbonnais, Illinois, 60914, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

dorzolamide

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Officials

  • William C. Stewart, MD

    Pharmaceutical Research Network, LLC

    STUDY DIRECTOR

  • Jay Mulaney, MD

    Central Florida Eye Associates

    PRINCIPAL INVESTIGATOR

  • Sriram Sonty, MD, FACS

    Midwest Eye Center SC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 9, 2006

Study Start

April 1, 2005

Study Completion

December 1, 2005

Last Updated

January 9, 2007

Record last verified: 2007-01

Locations

US(2)