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Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Bimatoprost and Bimatoprost/Timolol fixed combination.
Sponsored by
Larissa University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Ocular Hypertension, Lumigan, Ganfort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Eye Clinic

Outcomes

Primary Outcome Measures

Mean diurnal intraocular pressure

Secondary Outcome Measures

Full Information

First Posted
July 16, 2009
Last Updated
November 29, 2010
Sponsor
Larissa University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00941096
Brief Title
Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination
Official Title
Efficacy Of The Bimatoprost/Timolol Fixed Combination In Patients Treated With Bimatoprost for Primary Open Angle Glaucoma, Exfoliation Glaucoma or Ocular Hypertension.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Larissa University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
Glaucoma, Ocular Hypertension, Lumigan, Ganfort

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bimatoprost and Bimatoprost/Timolol fixed combination.
Other Intervention Name(s)
Lumigan, Ganfort
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean diurnal intraocular pressure
Time Frame
Five weeks on each medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
University Eye Clinic
City
Larissa
State/Province
Thessaly
ZIP/Postal Code
41110
Country
Greece

12. IPD Sharing Statement

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Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination

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