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GANfort® in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Are Insufficiently Responsive to Monotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01628601
First Posted: June 27, 2012
Last Update Posted: September 24, 2012
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.
Information provided by (Responsible Party):
Allergan
  Purpose
This is an observational study of patients diagnosed with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) who are insufficiently responsive to monotherapy and who are prescribed GANfort® (fixed combination of 0.3 mg bimatoprost and 5 mg timolol) by their physician.

Condition Intervention
Glaucoma, Open-Angle Ocular Hypertension Drug: Fixed combination 0.3 mg bimatoprost and 5 mg timolol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 18 Weeks ]
    IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.


Secondary Outcome Measures:
  • Physician Assessment of Tolerability Using a 4-Point Scale [ Time Frame: 18 Weeks ]
    Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.

  • Patient Assessment of Tolerability Using a 4-Point Scale [ Time Frame: 18 Weeks ]
    Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.

  • Physician Assessment of Adherence to GANfort® [ Time Frame: 18 Weeks ]
    Physician Assessment of Adherence to GANfort® was assessed on a 3-point scale (better, equal, and worse). The number of patients assessed as "better" compliance are reported.

  • Patients Continuing With GANfort® After 18 Weeks [ Time Frame: 18 Weeks ]
    Patients continuing with GANfort® after 18 weeks was assessed as Yes or No.


Enrollment: 392
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
POAG or OHT
Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
Drug: Fixed combination 0.3 mg bimatoprost and 5 mg timolol
Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary open angle glaucoma or ocular hypertension prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) by the physician prior to study entry
Criteria

Inclusion Criteria:

  • Diagnosis of primary open angle glaucoma or ocular hypertension
  • Prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol)

Exclusion Criteria:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01628601


Locations
Austria
Vienna, Austria
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01628601     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/027
First Submitted: June 25, 2012
First Posted: June 27, 2012
Results First Submitted: August 21, 2012
Results First Posted: September 24, 2012
Last Update Posted: September 24, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Bimatoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents