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Intraocular Pressure Reduction With the Bimatoprost/Timolol Fixed Combination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00941096
Recruitment Status : Completed
First Posted : July 17, 2009
Last Update Posted : November 30, 2010
Information provided by:
Larissa University Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

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

Primary Outcome Measures :
  1. Mean diurnal intraocular pressure [ Time Frame: Five weeks on each medication ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00941096

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University Eye Clinic
Larissa, Thessaly, Greece, 41110
Sponsors and Collaborators
Larissa University Hospital
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Responsible Party: Andreas Katsanos, MD, PhD, Larissa University Hospital Identifier: NCT00941096    
Other Study ID Numbers: 17062009-136
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: November 30, 2010
Last Verified: November 2010
Keywords provided by Larissa University Hospital:
Ocular Hypertension
Additional relevant MeSH terms:
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Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents