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NCT00440011 Clinical Trial

Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005%

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00440011
Other study ID # MA-LUM01
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 2006
Est. completion date October 2007

Study information
Verified date April 2019
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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%

Recruitment information / eligibility
Status Completed
Enrollment 266
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Secondary glaucoma

- Active intraocular inflammation or macular edema

- Intraocular surgery or laser surgery within the past 3 months

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• bimatoprost 0.03% eye drops
bimatoprost 0.03% 1 drop nightly for 3 months
• travoprost 0.004% eye drops
travoprost 0.004% 1 drop nightly for 3 months

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular Pressure (IOP) Intraocular Pressure Month 3
Secondary Tolerability - Conjunctival Hyperemia Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe) Month 3
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