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Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time

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: NCT01417013
Recruitment Status : Withdrawn (Management Decision)
First Posted : August 16, 2011
Last Update Posted : February 8, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary objective of this study is assess the Tear Film break-up time (TBUT) in mild to moderate dry eye subjects.

Condition or disease Intervention/treatment
Dry Eye Other: Systane Ultra Other: Optive

Detailed Description:
The primary objective of this study is assess the tear film break-up time in mild to moderate dry eye subjects.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up Time
Study Start Date : July 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Systane Ultra
Systane Ultra Lubricant Eye Drops
Other: Systane Ultra
Lubricant Eye Drops
Other Name: Systane Ultra Lubricant Eye Drops
Active Comparator: Optive
Optive Lubricant eye drops
Other: Optive
Lubricant eye drops
Other Name: Optive Lubricant eye drops


Outcome Measures

Primary Outcome Measures :
  1. TBUT [ Time Frame: 14 Days ]
    Tear Film break-up time


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:   Yes
Criteria

Inclusion Criteria:

  • Corrected VA of 0.6 LogMar or better OU

Exclusion:

  • Topical ocular medication use
  • Presence of Ocular conditions (blepharitis, conjunctival infections, etc)
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01417013     History of Changes
Other Study ID Numbers: SMA-10-07
First Posted: August 16, 2011    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012

Keywords provided by Alcon Research:
Dry eye or lubricant eye drops

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