Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005%
1 other identifier
interventional
266
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2006
1 active site
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
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 22, 2007
CompletedFirst Posted
Study publicly available on registry
February 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
September 26, 2008
CompletedApril 25, 2019
April 1, 2019
1.2 years
February 22, 2007
September 25, 2008
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
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
bimatoprost 0.03% 1 drop nightly for 3 months
travoprost 0.004% 1 drop nightly for 3 months
Eligibility Criteria
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
- Allerganlead
Study Sites (1)
Unknown Facility
San Diego, California, United States
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Affairs
Allergan
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