Lumigan Versus Cosopt | NCT00273455

Studies
Lumigan Versus Cosopt

NCT00273455

Sponsor

Pharmaceutical Research Network

Status

Completed

Last Update Posted

Nov 19, 2008Estimated

Enrollment

Phase

Phase 4

Conditions

Open-Angle Glaucoma

Interventions

bimatoprost 0.03%
dorzolamide 2%/timolol maleate 0.5% fixed combination
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

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

Jan 2006

Primary Completion Date

Not provided

Completion Date

May 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 compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients 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 a diagnosis of bilateral open-angle glaucoma including: primary, pigment dispersion or exfoliation in both eyes
on no therapy the intraocular pressure should be 22-29 mm Hg inclusive at the 8:00 AM measurement
visual acuity should be 20/200 or better in each eye

Exclusion Criteria:

historical failure to respond to topical beta-blockers in a clinically meaningful manner
any contraindication to study medications
any anticipated change, or modification in the 6 weeks prior to Visit 1, 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
Robert D. Williams, MD	Taustine Eye Center	Principal Investigator
Robert H. Stewart, MD	Houston Eye Associates	Principal Investigator
Elizabeth D. Sharpe, MD	Glaucoma Consultants & Center for Eye Research, PA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taustine Eye Center		Louisville	Kentucky	40217	United States
Glaucoma Consultants & Center for Eye Research, PA

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C062765	dorzolamide
D013999	Timolol

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
bimatoprost 0.03%	Drug
dorzolamide 2%/timolol maleate 0.5% fixed combination	Drug
placebo	Drug