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A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01589510
First received: April 30, 2012
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.


Condition Intervention
Glaucoma, Open-Angle
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:
  • Intraocular Pressure (IOP) [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician Assessment of Effect on IOP [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Patient Assessment of Tolerability [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Physician Assessment of Tolerability [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients who Discontinued Treatment [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients who Continued Treatment [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients who Maintained Compliance with Treatment [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]

Enrollment: 419
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lumigan® 0.01%
Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice.
 Drug: bimatoprost 0.01% ophthalmic solution
Bimatoprost 0.01% ophthalmic solution (Lumigan® 0.01%) as prescribed by physician per standard practice.
Other Name: Lumigan® 0.01%

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with POAG and 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: NCT01589510

Locations
Austria
Vienna, Austria
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01589510     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/034
Study First Received: April 30, 2012
Last Updated: April 22, 2013
Health Authority: Austria: Ethikkommission

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 21, 2013