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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01417013
First received: August 12, 2011
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  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 Blind (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:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • TBUT [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01417013     History of Changes
Other Study ID Numbers: SMA-10-07
Study First Received: August 12, 2011
Last Updated: February 6, 2012
Health Authority: Italy: National Bioethics Committee

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

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Tetrahydrozoline
 Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013