NCT00379834

Brief Summary

To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2006

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

September 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

February 10, 2015

Completed
Last Updated

February 10, 2015

Status Verified

January 1, 2015

Enrollment Period

1.6 years

First QC Date

September 21, 2006

Results QC Date

July 25, 2013

Last Update Submit

January 26, 2015

Conditions

Glaucoma

Keywords

glaucomadiurnalintraocular pressure

Outcome Measures

Primary Outcomes (1)

  • Diurnal Intraocular Pressure Control

    Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)

    12 months

Study Arms (1)

Cosopt

ACTIVE COMPARATOR

Cosopt twice daily in both eyes

Drug: Cosopt

Interventions

CosoptDRUG

Cosopt twice daily in both eyes

Also known as: Dorzolamide/timolol fixed combination
Cosopt

Eligibility Criteria

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

You may qualify if:

  • bilateral open-angle glaucoma

You may not qualify if:

  • contraindications to Cosopt
  • pathology affecting tonometry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma

Interventions

dorzolamide-timolol combinationdorzolamide

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
Dr. Tony Realini
Organization
West Virginia University
realinia@wvuhealthcare.com
3045986926

Study Officials

  • Anthony D Realini, MD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 21, 2006

First Posted

September 25, 2006

Study Start

September 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

February 10, 2015

Results First Posted

February 10, 2015

Record last verified: 2015-01