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Fluorophotometry Evaluation of Lubricant Eye Drops

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00347854
First Posted: July 4, 2006
Last Update Posted: November 22, 2016
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 (Responsible Party):
Alcon Research
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Fluorophotometry Evaluation of Lubricant Eye Drops FID 105783

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 18 and over

Exclusion Criteria:

  • No sodium fluorescein corneal staining at Screening Visit
  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): 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

Publications:
http://www.aaopt.org/evaluation-new-preservation-system-corneal-barrier-function

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00347854     History of Changes
Other Study ID Numbers: C-05-06
First Submitted: June 30, 2006
First Posted: July 4, 2006
Last Update Posted: November 22, 2016
Last Verified: February 2012

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

Additional relevant MeSH terms:
Ophthalmic Solutions
Tetrahydrozoline
Lubricant Eye Drops
Carboxymethylcellulose Sodium
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Laxatives
Gastrointestinal Agents