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

This study has been withdrawn prior to enrollment.
(Management Decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417013
First Posted: August 16, 2011
Last Update Posted: February 8, 2012
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 primary objective of this study is assess the Tear Film break-up time (TBUT) in mild to moderate dry eye subjects.

Condition Intervention
Dry Eye Other: Systane Ultra Other: Optive

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

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


Enrollment: 0
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01417013     History of Changes
Other Study ID Numbers: SMA-10-07
First Submitted: August 12, 2011
First Posted: August 16, 2011
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