Intraocular Pressure Reduction With the Bimatoprost/Timol... | NCT00941096

Studies
Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination

NCT00941096

Sponsor

Larissa University Hospital

Status

Completed

Last Update Posted

Nov 30, 2010Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Glaucoma
Ocular Hypertension

Interventions

Bimatoprost and Bimatoprost/Timolol fixed combination.

Countries

Greece

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 2010

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

Jul 2009

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Jul 16, 2009

First Submission Date that Met QC Criteria

Jul 16, 2009

First Posted Date

Jul 17, 2009Estimated

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 29, 2010

Last Update Posted Date

Nov 30, 2010Estimated

Description Module

Brief Summary

The purpose of this study is to examine the ocular hypotensive effect of Bimatoprost and the potential additional effect of the Bimatoprost/Timolol fixed combination in eyes with ocular hypertension, primary open angle glaucoma or exfoliation glaucoma.

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

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bimatoprost and Bimatoprost/Timolol fixed combination.	Drug	Following an appropriate wash-out period, participants were given a 5-week long treatment with Bimatoprost 0.03% once daily in the evening followed by a further 5-week long treatment with the Bimatoprost 0.03%/Timolol 0.5% fixed combination administered in the evening.		Lumigan Ganfort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean diurnal intraocular pressure		Five weeks on each medication

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary open angle glaucoma
Exfoliation glaucoma
Ocular hypertension

Exclusion Criteria:

Younger than 18 years old
Inability to understand and/or follow study requirements
Women of childbearing potential not using reliable birth control, pregnant or lactating women
History of chronic obstructive pulmonary disease, heart failure, 2nd or 3rd AV block
Anticipated modification of treatment for systemic hypertension during the study period
History of ocular herpes, corneal scarring, conventional or laser surgery or macular pathology
History of allergy, poor tolerability or poor response to study medication
Best corrected visual acuity less than 0.4
Significant visual field defect (MD<15.0 dB)

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Clinic		Larissa	Thessaly	41110	Greece

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069580	Bimatoprost
C571755	Ganfort

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided