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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01833741
Other study ID # CLEAR
Secondary ID
Status Completed
Phase Phase 4
First received April 15, 2013
Last updated September 24, 2013
Start date December 2009
Est. completion date March 2011

Study information

Verified date September 2013
Source Allergan
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1137
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

- Determined by the treating physician to require treatment with LUMIGANĀ® RC

Exclusion Criteria:

Study Design

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


Intervention

Drug:
Bimatoprost 0.01%
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Treatment-Naive Patients With Ocular Hyperemia 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. Week 12 No
Primary Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia 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. Week 12 No
Primary Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia 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. Week 12 No
Secondary Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients 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). Baseline, 12 Weeks No
Secondary Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients 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). Baseline, 12 Weeks No
Secondary Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy 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). Baseline, 12 Weeks No
Secondary Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients 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). Baseline, Week 6, Week 12 No
Secondary Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients 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). Baseline, Week 6, Week 12 No
Secondary Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy 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). Baseline, Week 6, Week 12 No
Secondary Percentage of Patients Discontinuing Due to Ocular Adverse Events Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment. 12 Weeks No
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