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OpenTrials
Completed

NCT Number: NCT01568008

Observational Study of Lumigan® 0.01% for Treatment of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

This is an observational study in patients with POAG or OHT that will collect data on the use of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting. Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after baseline, as per normal clinical practice.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent, Oost-Vlaanderen, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of POAG or OHT
  • Prescribed Lumigan® 0.01%

Exclusion criteria

  • None

Treatment and study plan

Bimatoprost 0.01% ophthalmic solution

Drug

Bimatoprost 0.01% ophthalmic solution eye drops at a dose and frequency as determined by the physician.

Other names: Lumigan®

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 eye and the right eye at Week 12. The lower the IOP values the greater the improvement.

Secondary outcomes

  1. Patient Assessment of Treatment Tolerability Using a 4-Point Scale

    Time frame: 12 weeks

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

  2. Physician Assessment of Treatment Tolerability Using a 4-Point Scale

    Time frame: 12 weeks

    The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.

  3. Physician Reported Reasons for Treatment Discontinuation

    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.

  4. Number of Patients Continuing Treatment After 12 Weeks

    Time frame: 12 weeks

    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
2012
Study completion
2012
First posted
Apr 2, 2012
Registry last updated
Sep 20, 2013

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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