Text Size

Observational Study of Lumigan® 0.01% for Treatment of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01568008
First received: March 29, 2012
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

This is an observational study in patients with POAG or OHT that will collect data on the use of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting. Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after baseline, as per normal clinical practice.


Condition Intervention
Open-Angle Glaucoma
Ocular Hypertension
 Drug: Bimatoprost 0.01% ophthalmic solution

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Drug Information available for: Bimatoprost
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IOP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patient Assessment of Treatment Tolerability Using a 4-Point Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Physician Assessment of Treatment Tolerability Using a 4-Point Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Physician Reported Reasons for Treatment Discontinuation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of Patients Continuing Treatment After 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 933
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lumigan® 0.01%
Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) at a dose and frequency as determined by the physician.
 Drug: Bimatoprost 0.01% ophthalmic solution
Bimatoprost 0.01% ophthalmic solution eye drops at a dose and frequency as determined by the physician.
Other Name: Lumigan®

  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

Patients with POAG or OHT

Criteria

Inclusion Criteria:

  • Diagnosis of POAG or OHT
  • Prescribed Lumigan® 0.01%

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568008

Locations
Belgium
Gent, Oost-Vlaanderen, Belgium
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01568008     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/031
Study First Received: March 29, 2012
Last Updated: January 18, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Bimatoprost
Cloprostenol
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013