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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440011
First Posted: February 26, 2007
Last Update Posted: July 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Allergan
  Purpose
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%

Condition Intervention Phase
Glaucoma Ocular Hypertension Drug: bimatoprost 0.03% eye drops Drug: travoprost 0.004% eye drops Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Intraocular Pressure (IOP) [ Time Frame: Month 3 ]
    Intraocular Pressure


Secondary Outcome Measures:
  • Tolerability - Conjunctival Hyperemia [ Time Frame: Month 3 ]
    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)


Enrollment: 266
Study Start Date: August 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bimatoprost 0.03% eye drops
bimatoprost 0.03% 1 drop nightly for 3 months
Other Name: Lumigan®
Active Comparator: 2 Drug: travoprost 0.004% eye drops
travoprost 0.004% 1 drop nightly for 3 months
Other Name: Travatan®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440011


Locations
United States, California
San Diego, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Affairs Allergan
  More Information

Responsible Party: Medical Affairs Director, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00440011     History of Changes
Other Study ID Numbers: MA-LUM01
First Submitted: February 22, 2007
First Posted: February 26, 2007
Results First Submitted: September 25, 2008
Results First Posted: September 26, 2008
Last Update Posted: July 22, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Tetrahydrozoline
Bimatoprost
Travoprost
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antihypertensive Agents


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