NCT00348023

Brief Summary

Evaluate the IOP-lowering efficacy and quality of life in patients using bimatoprost 0.03% monotherapy versus dual therapy with travoprost 0.004% and timolol 0.5% for the treatment of glaucoma or ocular hypertension.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

February 9, 2007

Status Verified

February 1, 2007

First QC Date

June 30, 2006

Last Update Submit

February 7, 2007

Conditions

Glaucoma

Interventions

Bimatoprost 0.03%, Travoprost 0.004%, Timolol 0.5%DRUG

Eligibility Criteria

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

You may qualify if:

  • · Male or female \> 18 years of age
  • Diagnosis of primary open-angle glaucoma or ocular hypertension
  • Untreated IOP \> 18 mm Hg in each eye at the baseline evaluation
  • Ability to provide informed consent and likely to complete all study visits

You may not qualify if:

  • · Known contraindication to bimatoprost, travoprost, timolol, or any component of any study medication
  • Uncontrolled systemic disease
  • Active ocular disease other than POAG or ocular hypertension
  • Required use of ocular medications other than the study medications during the study (intermittent use of OTC artificial tear products will be permitted)
  • History of intraocular surgery within the last 3 months
  • Patient must not have discontinued use of any medication included in this study in the past for reasons of efficacy or intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Noecker

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

BimatoprostTravoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Robert Noecker, MD

    UPMC Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Last Updated

February 9, 2007

Record last verified: 2007-02

Locations

US(1)