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OpenTrials
Completed

NCT Number: NCT01735214

An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments

This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies with the physician according to their standard practice.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of primary open angle glaucoma (POAG) or ocular hypertension (OHT)
  • Previously prescribed any IOP-lowering therapy which has been stopped and a new prostaglandin analogue -containing IOP-lowering therapy started

Exclusion criteria

  • None

Treatment and study plan

Prostaglandin Analogue -Containing IOP-Lowering Therapy

Drug

Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.

Primary outcomes

  1. Change From Baseline in Intraocular Pressure (IOP) in the Right Eye

    Time frame: Baseline, Week 12

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

  2. Change From Baseline in Intraocular Pressure (IOP) in the Left Eye

    Time frame: Baseline, Week 12

    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 Overall Tolerability With New Treatment Using a 4-Point Scale

    Time frame: 12 Weeks

    The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.

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

    Time frame: 12 Weeks

    The physician evaluated the patient's tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.

  3. Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks

    Time frame: 12 Weeks

  4. Percentage of Participants Who Continue the New Treatment After 12 Weeks

    Time frame: 12 Weeks

  5. Physician Assessment of Adherence to New Treatment Using a 4-Point Scale

    Time frame: 12 Weeks

    The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported.

  6. Physician Assessment of Efficacy Using a 5-Point Scale

    Time frame: 12 Weeks

    The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported.

  7. Percentage of Participants Reaching Individual IOP Target After 12 Weeks

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 28, 2012
Registry last updated
Apr 18, 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.

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