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Acute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops

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ClinicalTrials.gov Identifier: NCT00756093
Recruitment Status : Completed
First Posted : September 19, 2008
Results First Posted : March 11, 2010
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
To evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients

Condition or disease Intervention/treatment Phase
Dry Eye Other: Systane Ultra Lubricant Eye Drops Other: Optive Lubricant Eye Drops Other: Blink Tears Other: GenTeal Moderate Lubricant Eye Drops Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : September 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Systane Ultra Lubricant Eye Drops
Systane Ultra Lubricant Eye Drops 1 drop each one time
Other: Systane Ultra Lubricant Eye Drops
Systane Ultra Lubricant Eye Drops one drop each eye one time

Active Comparator: Optive Lubricant Eye Drops
Optive Lubricant Eye Drops 1 drop each eye one time
Other: Optive Lubricant Eye Drops
Optive Lubricant Eye Drops one drop each eye one time

Active Comparator: Blink Tears
Blink Tears 1 drop each eye one time
Other: Blink Tears
Blink Tears one drop each eye one time

Active Comparator: GenTeal Moderate Lubricant Eye Drops
GenTeal Moderate Lubricant Eye Drops 1 drop each eye one time
Other: GenTeal Moderate Lubricant Eye Drops
GenTeal Moderate Lubricant Eye Drops one drop each eye one time




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



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

Inclusion Criteria:

  • documented diagnosis of dry eye

Exclusion Criteria:

  • use of topical ocular drops within 2 hours preceding enrollment

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): NCT00756093


Locations
United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00756093     History of Changes
Other Study ID Numbers: M-08-10
First Posted: September 19, 2008    Key Record Dates
Results First Posted: March 11, 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