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

ClinicalTrials.gov processed this record on April 21, 2014