Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination

• Sponsor: Larissa University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00941096
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 16
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Drug: Bimatoprost and Bimatoprost/Timolol fixed combination.	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Jul 1, 2009
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Outcome Measures

Primary Outcome Measures

1. Mean diurnal intraocular pressure [Five weeks on each medication]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Eye Clinic	Larissa	Thessaly	Greece	41110

Sponsors and Collaborators

• Larissa University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00941096
• Other Study ID Numbers: 17062009-136
• First Posted: Jul 17, 2009
• Last Update Posted: Nov 30, 2010
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: Glaucoma; Ocular Hypertension; Lumigan; Ganfort
• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension; Timolol; Bimatoprost

Study Results

No Results Posted as of Nov 30, 2010