A Study of LUMIGAN® RC in the Clinical Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01833741
First received: April 15, 2013
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) in a clinical setting.


Condition Intervention Phase
Glaucoma, Primary Open Angle
Ocular Hypertension
Drug: Bimatoprost 0.01%
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Treatment-Naive Patients With Ocular Hyperemia [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry.

  • Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment.

  • Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy.


Secondary Outcome Measures:
  • Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. Naive patients did not use glaucoma medication prior to study entry. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).

  • Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).

  • Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).

  • Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients [ Time Frame: Baseline, Week 6, Week 12 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).

  • Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients [ Time Frame: Baseline, Week 6, Week 12 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).

  • Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy [ Time Frame: Baseline, Week 6, Week 12 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).

  • Percentage of Patients Discontinuing Due to Ocular Adverse Events [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment.


Enrollment: 1137
Study Start Date: December 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bimatoprost 0.01%
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Drug: Bimatoprost 0.01%
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Other Name: LUMIGAN® RC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
  • Determined by the treating physician to require treatment with LUMIGAN® RC

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: NCT01833741

Locations
Canada, Ontario
Barrie, Ontario, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01833741     History of Changes
Other Study ID Numbers: CLEAR
Study First Received: April 15, 2013
Results First Received: July 9, 2013
Last Updated: September 24, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Glaucoma
Bimatoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014