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OpenTrials
Completed

NCT Number: NCT01489670

Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension

This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bülach, Canton of Zurich, Switzerland

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
  • Lumigan® 0.01% prescribed either as monotherapy or adjunctive to beta-blocker therapy

Exclusion criteria

  • None

Treatment and study plan

Bimatoprost 0.01% ophthalmic solution

Drug

Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.

Other names: Lumigan® 0.01%

Primary outcomes

  1. Intraocular Pressure (IOP) at Baseline

    Time frame: Baseline

    IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.

  2. Intraocular Pressure (IOP) at Week 12

    Time frame: Week 12

    IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.

Secondary outcomes

  1. Physician Evaluation of Efficacy Using a 5-Point Scale

    Time frame: Week 12

    The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported.

  2. Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale

    Time frame: Week 12

    Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported.

  3. Physician Evaluation of Tolerability of Treatment

    Time frame: Week 12

    The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported.

  4. Physician Reported Reasons for Early Discontinuation of Treatment

    Time frame: 12 Weeks

    The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.

  5. Number of Patients Continuing Treatment After 12 Weeks

    Time frame: Week 12

    The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 12, 2011
Registry last updated
Mar 28, 2014

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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