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: May 20, 2015
Last verified: May 2015
  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 ] [ 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.


Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735214

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01735214     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/037
Study First Received: November 26, 2012
Results First Received: April 10, 2015
Last Updated: May 20, 2015
Health Authority: Turkey: Ethics Committee

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

ClinicalTrials.gov processed this record on August 03, 2015