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Short Term Comparative Study of Xalatan With Benzalkonium Chloride vs. Travatan Z Without Benzalkonium Chloride in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00468988
First received: May 2, 2007
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

Compare the effect of Xalatan with benzalkonium chloride on the ocular surface to those effects observed with Travatan Z without benzalkonium chloride after a single dose


Condition Intervention Phase
Glaucoma
 Drug: Travatan® Z
Drug: Xalatan®
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Short Term Comparative Study of Xalatan With Benzalkonium Chloride vs. Travatan Z Without Benzalkonium Chloride in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Tear Break Up Time [ Time Frame: Day ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Onset ]

Estimated Enrollment: 30
Study Start Date: May 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma

Exclusion Criteria:

  • Age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468988

Locations
United States, Florida
Orlando
Orlando, Florida, United States, 32801
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Mark Jasek, PhD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00468988     History of Changes
Other Study ID Numbers: SMA-06-21
Study First Received: May 2, 2007
Last Updated: May 23, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Benzalkonium Compounds
Latanoprost
Travoprost
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013