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OpenTrials
Completed

NCT Number: NCT01646151

A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

Dresden, Germany

Loading trial locations.

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
  • Previous use of IOP-lowering medication

Exclusion criteria

  • None

Treatment and study plan

Bimatoprost

Drug

Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.

Other names: LUMIGAN®, GANFORT®

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 12

    Time frame: Week 12

    IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.

Secondary outcomes

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

    Time frame: Week 12

    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 12

    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 12

    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. Physician Assessment of Patient Compliance Compared to Previous Therapy

    Time frame: Week 12

    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.

  5. Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment

    Time frame: 12 Weeks

    Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.

  6. Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops

    Time frame: Week 12

    Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 20, 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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