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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01735214
First Posted: November 28, 2012
Last Update Posted: June 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
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.

Condition Intervention
Glaucoma, Open-Angle Ocular Hypertension Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.

  • 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.

  • Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks [ Time Frame: 12 Weeks ]
  • Percentage of Participants Who Continue the New Treatment After 12 Weeks [ Time Frame: 12 Weeks ]
  • 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.

  • 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.

  • Percentage of Participants Reaching Individual IOP Target After 12 Weeks [ Time Frame: 12 Weeks ]

Enrollment: 358
Study Start Date: March 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with POAG or OHT
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.
Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
POAG or OHT
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735214


Locations
Turkey
Istanbul, Turkey
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01735214     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/037
First Submitted: November 26, 2012
First Posted: November 28, 2012
Results First Submitted: April 10, 2015
Results First Posted: April 27, 2015
Last Update Posted: June 15, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases
Eye Diseases