Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination

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

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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
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Please refer to this study by its identifier: NCT00941096

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 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:
Ocular Hypertension

Additional relevant MeSH terms:
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on October 08, 2015