A Study of LUMIGAN® RC in the Clinical Setting

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833741
• Other study ID #: CLEAR
• 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 LUMIGAN® RC

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle
• Ocular Hypertension

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