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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
History of Changes
  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:

U.S. FDA Resources

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
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:
Glaucoma
Hypertension
Ocular Hypertension
Exfoliation Syndrome
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Iris Diseases
Uveal 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 May 19, 2013