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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

April 15, 2013
September 24, 2013
December 2009
March 2011   (final data collection date for primary outcome measure)
  • 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.
Percentage of Patients with Ocular Hyperemia [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01833741 on ClinicalTrials.gov Archive Site
  • 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.
  • Percent Change from Baseline in Intraocular Pressure (IOP) in Naïve Patients [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in IOP in Previously Treated (Switched) Patients [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Average Eye IOP [ Time Frame: Baseline, Week 6, Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Patients Discontinuing Due to Adverse Events [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in IOP in Patients Treated with Adjunctive Therapy [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of LUMIGAN® RC in the Clinical Setting
Not Provided

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glaucoma, Primary Open Angle
  • Ocular Hypertension
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
Experimental: Bimatoprost 0.01%
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Intervention: Drug: Bimatoprost 0.01%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1137
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01833741
CLEAR
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP