Cosopt Versus Xalatan | NCT00273429

Studies
Cosopt Versus Xalatan

NCT00273429

Sponsor

Pharmaceutical Research Network

Status

Completed

Last Update Posted

Jan 9, 2007Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Open-Angle Glaucoma
Ocular Hypertension

Interventions

timolol maleate 0.5%
dorzolamide/timolol maleate fixed combination
latanoprost 0.005%
placebo

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

Jan 2007

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

Apr 2005

Primary Completion Date

Not provided

Completion Date

Dec 2005

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

Jan 8, 2007

Last Update Posted Date

Jan 9, 2007Estimated

Description Module

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.

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

Not provided

Eligibility Module

Eligibility Criteria

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

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
Jay Mulaney, MD	Central Florida Eye Associates	Principal Investigator
Sriram Sonty, MD, FACS	Midwest Eye Center SC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Florida Eye Associates		Lakeland	Florida	33805	United States
Midwest Eye Center SC

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

Ancestor Terms

ID	Term
D005901	Glaucoma
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C062765	dorzolamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
timolol maleate 0.5%	Drug
dorzolamide/timolol maleate fixed combination	Drug
latanoprost 0.005%	Drug
placebo	Drug