NCT01271686

Brief Summary

This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 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

January 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

June 19, 2014

Completed
Last Updated

June 19, 2014

Status Verified

May 1, 2014

Enrollment Period

1.8 years

First QC Date

January 6, 2011

Results QC Date

December 17, 2013

Last Update Submit

May 19, 2014

Conditions

Intraocular PressureGlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Nocturnal Intraocular Pressure (IOP) Change

    Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.

    4 weeks

Study Arms (1)

0.01% bimatoprost

EXPERIMENTAL

bimatoprost 0.01% one time per day at bedtime for 4 weeks.

Drug: 0.01% bimatoprost

Interventions

0.01% bimatoprostDRUG

0.01% bimatoprost once in the evening for 4 weeks

Also known as: Lumigan 0.01%
0.01% bimatoprost

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary open-angle glaucoma or ocular hypertension

You may not qualify if:

  • Women of childbearing potential previous glaucoma surgery presence of other eye disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Shiley Eye Center

La Jolla, California, 92093, United States

Location

Related Publications (1)

  • Tung JD, Tafreshi A, Weinreb RN, Slight JR, Medeiros FA, Liu JH. Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure. BMJ Open. 2012 Aug 23;2(4):e001106. doi: 10.1136/bmjopen-2012-001106. Print 2012.

    PMID: 22918671RESULT

Related Links

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. John Liu
Organization
University of California, San Diego
joliu@ucsd.edu
858 534-7056

Study Officials

  • John Liu, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

January 6, 2011

First Posted

January 7, 2011

Study Start

January 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

June 19, 2014

Results First Posted

June 19, 2014

Record last verified: 2014-05

Locations

US(1)