Diurnal Curves With Bimatoprost 0.03% Versus Travoprost 0... | NCT00347802

Studies
Diurnal Curves With Bimatoprost 0.03% Versus Travoprost 0.004%

NCT00347802

Sponsor

Innovative Medical

Status

Completed

Last Update Posted

Jun 1, 2007Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Glaucoma

Interventions

Bimatoprost 0.03%, Travoprost 0.004%

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

May 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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Jun 30, 2006

First Posted Date

Jul 4, 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

May 30, 2007

Last Update Posted Date

Jun 1, 2007Estimated

Description Module

Brief Summary

To compare the diurnal curves in patients using bimatoprost 0.03% versus travoprost 0.004% for the treatment of glaucoma or ocular hypertension.

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

Name	Type	Description	Arm Group Labels	Other Names
Bimatoprost 0.03%, Travoprost 0.004%	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

· Male or female > 18 years of age
- Naive to treatment or washed off any ocular hypotensive agents
- Untreated IOP >19 mm Hg
- Diagnosis of open-angle glaucoma or ocular hypertension
- Ability to provide informed consent and likely to complete study

Exclusion Criteria:

· Known contraindication to bimatoprost or travoprost, or any component of any study medication
- Uncontrolled systemic disease
- Active ocular disease other than glaucoma or ocular hypertension
- Required use of ocular medications other than the study medications during the study
- History of intraocular surgery within the last 3 months
- Prior discontinuation of any of the study medications for reasons related to efficacy or safety

Accepts Healthy Volunteers

Not provided

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
Robert Noecker, MD	UPMC Eye Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Noecker		Pittsburgh	Pennsylvania	15213	United States

ID	Term
D005901	Glaucoma

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000069580	Bimatoprost

Ancestor Terms

ID	Term
D000577	Amides
D009930	Organic Chemicals
D003008	Cloprostenol
D011461	Prostaglandins F, Synthetic

Browse Leaves

Not provided

Browse Branches

Not provided