NCT00332059

Brief Summary

The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in patients with glaucoma or ocular hypertension

Trial Health

90
On Track

Trial Health Score

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

Enrollment
445

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2003

Shorter than P25 for phase_3

Geographic Reach
4 countries

4 active sites

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

May 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2006

Completed
Last Updated

May 30, 2011

Status Verified

May 1, 2011

Enrollment Period

1.3 years

First QC Date

May 30, 2006

Last Update Submit

May 27, 2011

Conditions

Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

  • IOP

Interventions

bimatoprost/timolol fixed combinationDRUG

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
  • Contraindication to beta-adrenoceptor antagonist therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Bel Air, Maryland, United States

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Berlin, Germany

Location

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 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2006

First Posted

June 1, 2006

Study Start

May 1, 2003

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

May 30, 2011

Record last verified: 2011-05

Locations

AU(1)US(1)CA(1)DE(1)