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Acute Comfort of Lubricant Eye Drop FID 111421

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.
ClinicalTrials.gov Identifier: NCT00673959
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : March 10, 2010
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the acute comfort and blurring profile between two artificial tears products in dry eye patients

Condition or disease Intervention/treatment
Dry Eye Other: Lubricant Eye Drop FID 111421 Other: Optive Lubricant Eye Drop

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2007
Primary Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lubricant Eye Drop FID 111421
Lubricant Eye Drop FID 111421 1 drop each eye one time
Other: Lubricant Eye Drop FID 111421
Lubricant Eye Drop FID 111421 1 drop each eye one time
Active Comparator: Optive Lubricant Eye Drop
Optive Lubricant Eye Drop 1 drop each eye one time
Other: Optive Lubricant Eye Drop
Optive Lubricant Eye Drop 1 drop each eye one time


Outcome Measures

Primary Outcome Measures :
  1. Drop Comfort Upon Instillation [ Time Frame: upon instillation ]
    Drop comfort grading scale is a scale from 0 to 9, with 0 meaning most comfortable and 9 meaning most uncomfortable.


Eligibility Criteria

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:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of dry eye
  • Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria:

  • Age related
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00673959     History of Changes
Other Study ID Numbers: C-07-08
First Posted: May 7, 2008    Key Record Dates
Results First Posted: March 10, 2010
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Alcon Research:
Dry eye
artificial tears

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