Assessing Cosopt Switch Patients | NCT00273442

Studies
Assessing Cosopt Switch Patients

NCT00273442

Sponsor

Pharmaceutical Research Network

Status

Completed

Last Update Posted

Nov 19, 2008Estimated

Enrollment

Phase

Phase 4

Conditions

Ocular Hypertension
Open-Angle Glaucoma
Exfoliation Syndrome
Glaucoma, Pigmentary

Interventions

timolol maleate
dorzolamide/timolol maleate fixed combination

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Jan 6, 2006

First Submission Date that Met QC Criteria

Jan 6, 2006

First Posted Date

Jan 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2008

Last Update Posted Date

Nov 19, 2008Estimated

Description Module

Brief Summary

To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults with clinical diagnosis of POAG, pigment-dispersion or exfoliation glaucoma or ocular hypertension
the IOP on latanoprost must be 31 mm Hg or less in both eyes, and 21 to 31 mm Hg inclusive in at least one eye at 08:00 AM
visual acuity should be 20/200 or better in each eye

Exclusion Criteria:

contraindications to study drugs
anticipated change in systemic hypotensive therapy during the trial
use of any corticosteroids by any route in the three months immediately prior to Visit 2

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William C. Stewart, MD	Pharmaceutical Research Network, LLC	Study Director
Mark J. Weiss, MD		Principal Investigator
Douglas G. Day, MD	Omni Eye Services	Principal Investigator
Sriram Sonty, MD, FACS	Midwest Eye Center	Principal Investigator
J. Charles Henry, MD	Little Rock Eye Clinic	Principal Investigator
Elizabeth D. Sharpe, MD	Glaucoma Consultants & Center for Eye Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Little Rock Eye Clinic		Little Rock	Arkansas	72205	United States
Omni Eye Services

Condition Browse Module

MeSH Terms

ID	Term
D009798	Ocular Hypertension
D005902	Glaucoma, Open-Angle
D017889	Exfoliation Syndrome

Ancestor Terms

ID	Term
D005128	Eye Diseases
D005901	Glaucoma
D007499	Iris Diseases
D014603	Uveal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013999	Timolol
C062765	dorzolamide

Ancestor Terms

ID	Term
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
timolol maleate	Drug
dorzolamide/timolol maleate fixed combination	Drug