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OpenTrials
Completed

NCT Number: NCT01589510

A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

16 year and older

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 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 (Lumigan® 0.01%) as prescribed by physician per standard practice for up to 14 weeks.

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 eyes at Baseline.

  2. IOP at Week 14

    Time frame: Week 14

    IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14.

Secondary outcomes

  1. Physician Evaluation of IOP Lowering in the Study Eye(s)

    Time frame: Week 14

    IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.

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

    Time frame: Week 14

    Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.

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

    Time frame: Week 14

    Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.

  4. Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment

    Time frame: 14 Weeks

    Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No.

  5. Percentage of Patients Who Continue Lumigan® 0.01% Treatment

    Time frame: Week 14

    Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No.

  6. Physician Assessment of Patient Compliance Compared to Previous Therapy

    Time frame: Week 14

    Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 2, 2012
Registry last updated
Jun 13, 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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