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An Evaluation of a Marketed Lubricated Eye Drop in Soft Contact Lens Wearers Who Experience Ocular Dryness

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01132287
First Posted: May 28, 2010
Last Update Posted: November 21, 2016
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
Study to evaluate subjective comfort associated with the use of a marketed lubricant eye drop, by subjects reporting ocular dryness and wearing soft contact lenses on a daily disposable replacement schedule.

Condition Intervention
Contact Lens Wear Other: FID 112903

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: An Evaluation of a Marketed Lubricated Eye Drop in Soft Contact Lens Wearers Who Experience Ocular Dryness

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Subjective Comfort [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Slit Lamp [ Time Frame: 14 Days ]
  • Visual Acuity [ Time Frame: 14 Days ]

Enrollment: 92
Study Start Date: April 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 FID 112903
FID 112903
Other: FID 112903
lubricant eye drop FID 112903
Other Name: Systane Ultra
No Intervention: No Intervention

Detailed Description:
The objective of this study is to evaluate subjective comfort associated with the use of a marketed lubricant eye drop, by subjects reporting ocular dryness and wearing soft contact lenses on a daily disposable replacement schedule.
  Eligibility

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:

  • Normal eyes

Exclusion Criteria:

  • Topical ocular medication use Unstable or active ocular issues
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01132287     History of Changes
Other Study ID Numbers: SMA-09-50
First Submitted: May 26, 2010
First Posted: May 28, 2010
Last Update Posted: November 21, 2016
Last Verified: January 2012

Keywords provided by Alcon Research:
Contact lens wear
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