NCT02020512

Brief Summary

This study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma and ocular hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2011

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

July 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 25, 2013

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 21, 2014

Completed
Last Updated

July 21, 2014

Status Verified

June 1, 2014

Enrollment Period

1.4 years

First QC Date

December 19, 2013

Results QC Date

June 24, 2014

Last Update Submit

June 24, 2014

Conditions

Glaucoma, Open-AngleOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Intraocular Pressure (IOP) in the Study Eye

    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 5

Study Arms (1)

0.03% Bimatoprost

EXPERIMENTAL

0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.

Drug: 0.03% Bimatoprost

Interventions

0.03% BimatoprostDRUG

0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.

Also known as: LUMIGAN®
0.03% Bimatoprost

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of open-angle glaucoma or ocular hypertension
  • No use of Lumigan® in the past 3 months

You may not qualify if:

  • Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Guangzhou, China

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsCloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

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

December 19, 2013

First Posted

December 25, 2013

Study Start

July 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 21, 2014

Results First Posted

July 21, 2014

Record last verified: 2014-06

Locations

CN(1)