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OpenTrials
Completed

NCT Number: NCT01628601

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

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.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fixed combination 0.3 mg bimatoprost and 5 mg timolol

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 27, 2012
Registry last updated
Sep 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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