NCT01833741

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,137

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
5 months until next milestone

Results Posted

Study results publicly available

September 26, 2013

Completed
Last Updated

September 26, 2013

Status Verified

September 1, 2013

Enrollment Period

1.2 years

First QC Date

April 15, 2013

Results QC Date

July 9, 2013

Last Update Submit

September 24, 2013

Conditions

Glaucoma, Primary Open AngleOcular Hypertension

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (7)

  • Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients

    Baseline, 12 Weeks

  • Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients

    Baseline, 12 Weeks

  • Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy

    Baseline, 12 Weeks

  • Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients

    Baseline, Week 6, Week 12

  • Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients

    Baseline, Week 6, Week 12

  • +2 more secondary outcomes

Study Arms (1)

Bimatoprost 0.01%

EXPERIMENTAL

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

Drug: Bimatoprost 0.01%

Interventions

Bimatoprost 0.01%DRUG

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

Also known as: LUMIGAN® RC
Bimatoprost 0.01%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Barrie, Ontario, Canada

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 17, 2013

Study Start

December 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 26, 2013

Results First Posted

September 26, 2013

Record last verified: 2013-09

Locations

CA(1)