Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination

This study has been completed.
Sponsor:
Information provided by:
Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT00941096
First received: July 16, 2009
Last updated: November 29, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Glaucoma
Ocular Hypertension
Drug: Bimatoprost and Bimatoprost/Timolol fixed combination.
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • Mean diurnal intraocular pressure [ Time Frame: Five weeks on each medication ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Names:
    • Lumigan
    • Ganfort
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941096

Locations
Greece
University Eye Clinic
Larissa, Thessaly, Greece, 41110
Sponsors and Collaborators
Larissa University Hospital
  More Information

No publications provided

Responsible Party: Andreas Katsanos, MD, PhD, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT00941096     History of Changes
Other Study ID Numbers: 17062009-136
Study First Received: July 16, 2009
Last Updated: November 29, 2010
Health Authority: Greece: Ethics Committee

Keywords provided by Larissa University Hospital:
Glaucoma
Ocular Hypertension
Lumigan
Ganfort

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Bimatoprost
Cloprostenol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on September 16, 2014