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OpenTrials
Completed

NCT Number: NCT01999348

A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting

The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.

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Key information

Conditions

Glaucoma, Primary Open Angle Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

Wiesloch, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with primary open-angle glaucoma or ocular hypertension
  • Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to GANFORT® UD for medical reasons

Exclusion criteria

  • None

Treatment and study plan

Fixed Combination Bimatoprost and Timolol

Drug

Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.

Other names: GANFORT® UD

Primary outcomes

  1. Change From Baseline in Intraocular Pressure (IOP) in the Study Eye

    Time frame: Baseline, Final Visit (Week 8 to 12)

    IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement).

Secondary outcomes

  1. Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale

    Time frame: Baseline, Final Visit (Week 8 to 12)

    The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported.

  2. Patient Assessment of Tolerability on a 4-Point Scale

    Time frame: Final Visit (Week 8 to 12)

    The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.

  3. Physician Assessment of Tolerability on a 4-Point Scale

    Time frame: Final Visit (Week 8 to 12)

    The physician assessed the patient's tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.

  4. Percentage of Patients Who Discontinued Treatment

    Time frame: 12 Weeks

    The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit

  5. Percentage of Patients Prescribed by the Physician to Continue Treatment

    Time frame: Final Visit (Week 8 to 12)

    The percentage of participants who continued treatment with Ganfort® UD after Week 12.

  6. Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale

    Time frame: Final Visit (Week 8 to 12)

    The physician assessed patient compliance with Ganfort® UD compared to previous treatment using a 3-point scale where: 1=better (best), 2=equal and 3=worse. The number of participants in each category is reported.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 3, 2013
Registry last updated
Apr 19, 2019

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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