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

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ClinicalTrials.gov Identifier: NCT01132287
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment Phase
Contact Lens Wear Other: FID 112903 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
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
Study Start Date : April 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: 1 FID 112903
FID 112903
Other: FID 112903
lubricant eye drop FID 112903
Other Name: Systane Ultra

No Intervention: No Intervention



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

Secondary Outcome Measures :
  1. Slit Lamp [ Time Frame: 14 Days ]
  2. Visual Acuity [ Time Frame: 14 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Publications of Results:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01132287     History of Changes
Other Study ID Numbers: SMA-09-50
First Posted: May 28, 2010    Key Record Dates
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