NCT00440011

Brief Summary

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%

Trial Health

87
On Track

Trial Health Score

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

Enrollment
266

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2006

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

August 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
12 months until next milestone

Results Posted

Study results publicly available

September 26, 2008

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

February 22, 2007

Results QC Date

September 25, 2008

Last Update Submit

April 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure (IOP)

    Intraocular Pressure

    Month 3

Secondary Outcomes (1)

  • Tolerability - Conjunctival Hyperemia

    Month 3

Study Arms (2)

1

EXPERIMENTAL
Drug: bimatoprost 0.03% eye drops

2

ACTIVE COMPARATOR
Drug: travoprost 0.004% eye drops

Interventions

bimatoprost 0.03% 1 drop nightly for 3 months

Also known as: Lumigan®
1

travoprost 0.004% 1 drop nightly for 3 months

Also known as: Travatan®
2

Eligibility Criteria

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

You may qualify if:

  • Glaucoma or ocular hypertension in both eyes
  • Currently being treated with latanoprost 0.005% daily and in need of additional IOP-lowering
  • Best-corrected visual acuity of 20/100 or better in each eye
  • Visual field within 6 months of study entry

You may not qualify if:

  • Secondary glaucoma
  • Active intraocular inflammation or macular edema
  • Intraocular surgery or laser surgery within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Diego, California, United States

Location

Related Publications (1)

  • Kammer JA, Katzman B, Ackerman SL, Hollander DA. Efficacy and tolerability of bimatoprost versus travoprost in patients previously on latanoprost: a 3-month, randomised, masked-evaluator, multicentre study. Br J Ophthalmol. 2010 Jan;94(1):74-9. doi: 10.1136/bjo.2009.158071. Epub 2009 Sep 1.

    PMID: 19726422BACKGROUND

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

BimatoprostOphthalmic SolutionsTravoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsCloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Results Point of Contact

Title
Vice President Medical Affairs
Organization
Allergan, Inc.

Study Officials

  • Medical Affairs

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 22, 2007

First Posted

February 26, 2007

Study Start

August 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

April 25, 2019

Results First Posted

September 26, 2008

Record last verified: 2019-04

Locations