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Fluorophotometry Evaluation of Lubricant Eye Drops

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00347854
First received: June 30, 2006
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

The objective of this study is to evaluate the safety and efficacy of exaggerated use of Lubricant Eye Drops in a population of normal subjects by measuring corneal epithelial permeability to fluorescein.


Condition Intervention
Healthy
 Other: Systane Free lubricant eye drops
Other: Visine Tears Lubricant Eye Drops
Other: Refresh Liquigel Lubricant Eye Drops
Other: Refresh Plus Lubricant Eye Drops

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Fluorophotometry Evaluation of Lubricant Eye Drops FID 105783

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Epithelial permeability to fluorescein

Secondary Outcome Measures:
  • tear turnover rate

Enrollment: 40
Study Start Date: April 2006
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FID 105783 Other: Systane Free lubricant eye drops
Active Comparator: Visine Other: Visine Tears Lubricant Eye Drops
Active Comparator: Refresh Liquigel Other: Refresh Liquigel Lubricant Eye Drops
Active Comparator: Refresh Plus Other: Refresh Plus Lubricant Eye Drops

  Eligibility

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

Inclusion Criteria:

  • Ages 18 and over

Exclusion Criteria:

  • No sodium fluorescein corneal staining at Screening Visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347854

Locations
United States, Texas
Alcon
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Mike Christensen Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00347854     History of Changes
Other Study ID Numbers: C-05-06
Study First Received: June 30, 2006
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Normal, healthy eyes (other than correction for visual acuity)

Additional relevant MeSH terms:
Tetrahydrozoline
Carboxymethylcellulose Sodium
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Laxatives
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013