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OpenTrials
Completed

NCT Number: NCT01637246

A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Were Insufficiently Responsive to Monotherapy

This is a retrospective chart review and will assess changes in IOP after treatment with any fixed combination in patients who previously received monotherapy.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of glaucoma or ocular hypertension
  • Previously treated with monotherapy followed by fixed combination therapy for at least 12 weeks

Exclusion criteria

  • None

Treatment and study plan

Any Fixed Combination Therapy

Drug

Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy. This was a retrospective chart review study, so no treatment was administered in this study.

Primary outcomes

  1. Change From Baseline in Intraocular Pressure (IOP)

    Time frame: Baseline, 12 Weeks

    IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.

Secondary outcomes

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

    Time frame: 12 Weeks

    Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.

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

    Time frame: 12 Weeks

    Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.

  3. Percentage of Patients Who Maintained Better Compliance With Treatment

    Time frame: 12 Weeks

    Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance).

  4. Percentage of Patients Continuing on Therapy After 12 Weeks

    Time frame: 12 Weeks

    Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 11, 2012
Registry last updated
Sep 21, 2012

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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