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

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ClinicalTrials.gov Identifier: NCT01628601
Recruitment Status : Completed
First Posted : June 27, 2012
Results First Posted : September 24, 2012
Last Update Posted : September 24, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Glaucoma, Open-Angle Ocular Hypertension Drug: Fixed combination 0.3 mg bimatoprost and 5 mg timolol

Study Design
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Study Type : Observational
Actual Enrollment : 392 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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:

  • None
Contacts and Locations
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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
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Austria
Vienna, Austria
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01628601    
Other Study ID Numbers: MAF/AGN/OPH/GLA/027
First Posted: June 27, 2012    Key Record Dates
Results First Posted: September 24, 2012
Last Update Posted: September 24, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Hypertension
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