NCT01628588

Brief Summary

This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
854

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

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

March 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
3 months until next milestone

Results Posted

Study results publicly available

September 24, 2012

Completed
Last Updated

September 24, 2012

Status Verified

August 1, 2012

Enrollment Period

9 months

First QC Date

June 25, 2012

Results QC Date

August 21, 2012

Last Update Submit

August 21, 2012

Conditions

Glaucoma, Open-AngleOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Intraocular Pressure (IOP)

    IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.

    Baseline, 14 Weeks

Secondary Outcomes (4)

  • Patient Assessment of Tolerability Using a 4-Point Scale

    14 Weeks

  • Physician Assessment of Tolerability Using a 4-Point Scale

    14 Weeks

  • Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks

    14 Weeks

  • Patients Who Will Continue Use of Lumigan® After 14 Weeks

    14 Weeks

Study Arms (1)

POAG or OHT

Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry

Drug: bimatoprost 0.01%

Interventions

bimatoprost 0.01%DRUG

Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry

POAG or OHT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with primary open angle glaucoma or ocular hypertension

You may qualify if:

  • Diagnosis of primary open angle glaucoma or ocular hypertension
  • Prescribed Lumigan®

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Amsterdam, Netherlands

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
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2012

First Posted

June 27, 2012

Study Start

March 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 24, 2012

Results First Posted

September 24, 2012

Record last verified: 2012-08

Locations

NL(1)