Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-11-30

Brief Summary

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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

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Conditions

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Glaucoma Ocular Hypertension

Keywords

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Glaucoma Ocular Hypertension Lumigan Ganfort

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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Bimatoprost and Bimatoprost/Timolol fixed combination.

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.

Intervention Type DRUG

Other Intervention Names

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Lumigan Ganfort

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Larissa University Hospital

Locations

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University Eye Clinic

Larissa, Thessaly, Greece

Site Status

Countries

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Greece

Other Identifiers

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17062009-136

Identifier Type: -

Identifier Source: org_study_id