Skip to main content
OpenTrials
Completed

NCT Number: NCT01853085

A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons

The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.

Completed

Looking for future studies?

Notify Me

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, Baden-Wurttemberg, 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 Lumigan® UD for medical reasons

Exclusion criteria

  • None

Treatment and study plan

Bimatoprost Ophthalmic Solution

Drug

Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.

Other names: Lumigan® UD

Primary outcomes

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

    Time frame: Baseline

    IOP is a measurement of the fluid pressure inside the study eye.

  2. IOP in the Study Eye at Week 12

    Time frame: Week 12

    IOP is a measurement of the fluid pressure inside the study eye.

Secondary outcomes

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

    Time frame: Baseline, 12 Weeks

    IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented.

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

    Time frame: 12 Weeks

    Patient assessment of tolerability is 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: 12 Weeks

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

  4. Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment

    Time frame: 12 Weeks

    Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No.

  5. Number of Patients Who Continue Treatment

    Time frame: 12 Weeks

    Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No.

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

    Time frame: 12 Weeks

    Physician assessment of patient compliance compared to previous therapy is 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
2013
Primary completion
2014
Study completion
2014
First posted
May 14, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.