Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination

Glaucoma Clinical Trial

Official title:

Efficacy Of The Bimatoprost/Timolol Fixed Combination In Patients Treated With Bimatoprost for Primary Open Angle Glaucoma, Exfoliation Glaucoma or Ocular Hypertension.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941096
• Other study ID #: 17062009-136
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2009
• Last updated: November 29, 2010
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: Larissa University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Greece	University Eye Clinic	Larissa	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean diurnal intraocular pressure		Five weeks on each medication	No