NCT00300443

Brief Summary

The purpose of this study is to assess the safety and efficacy of bimatoprost 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
561

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_2

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, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

May 30, 2011

Status Verified

May 1, 2011

Enrollment Period

1.5 years

First QC Date

March 7, 2006

Last Update Submit

May 27, 2011

Conditions

Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Lowering intraocular pressure (IOP)

Interventions

bimatoprostDRUG

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of glaucoma or ocular hypertension in both eyes
  • Patient requires IOP-lowering drug in both eyes

You may not qualify if:

  • Uncontrolled medical conditions
  • Ocular seasonal allergies within the past 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Newport Beach, California, United States

Location

Related Publications (1)

  • Katz LJ, Cohen JS, Batoosingh AL, Felix C, Shu V, Schiffman RM. Twelve-month, randomized, controlled trial of bimatoprost 0.01%, 0.0125%, and 0.03% in patients with glaucoma or ocular hypertension. Am J Ophthalmol. 2010 Apr;149(4):661-671.e1. doi: 10.1016/j.ajo.2009.12.003.

    PMID: 20346780DERIVED

MeSH Terms

Conditions

Ocular Hypertension

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 7, 2006

First Posted

March 9, 2006

Study Start

December 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

May 30, 2011

Record last verified: 2011-05

Locations

US(1)