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:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01735214
First received: November 26, 2012
Last updated: April 10, 2015
Last verified: April 2015

November 26, 2012
April 10, 2015
March 2013
April 2014   (final data collection date for primary outcome measure)
  • Change From Baseline in Intraocular Pressure (IOP) in the Right Eye [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01735214 on ClinicalTrials.gov Archive Site
  • Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Continue the New Treatment After 12 Weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Physician Assessment of Adherence to New Treatment Using a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Patient Assessment of Tolerability with New Treatment Using a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Physician Assessment of Tolerability with New Treatment Using a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients Who Discontinue the Use of New Treatment Prior to 12 Weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients who Continue the New Treatment After 12 Weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Physician Assessment of Adherence to New Treatment Using a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Physician Assessment of Efficacy Using a 5-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients Reaching Individual IOP Target After 12 Weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments
Not Provided

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

POAG or OHT

  • Glaucoma, Open-Angle
  • Ocular Hypertension
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.
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.
Intervention: Drug: Prostaglandin Analogue -Containing IOP-Lowering Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
402
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01735214
MAF/AGN/OPH/GLA/037
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP