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Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS)

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ClinicalTrials.gov Identifier: NCT00733291
Recruitment Status : Completed
First Posted : August 13, 2008
Results First Posted : December 21, 2011
Last Update Posted : December 28, 2011
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027.

Condition or disease Intervention/treatment Phase
Myopia Device: Nelfilcon A contact lens Device: Etafilcon A contact lens Device: FID 107027 solution Not Applicable

Detailed Description:
Corneal staining and subjective responses for ocular redness and comfort will be compared.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Study Start Date : January 2008
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Nelfilcon A soak / Nelfilcon A no-soak
Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
 Device: Nelfilcon A contact lens
Commercially marketed, single vision, soft contact lens for daily disposable wear
Other Name: Focus Dailies with AquaRelease

Device: FID 107027 solution
Commercially marketed solution for contact lens disinfection
Other Name: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution
Active Comparator: Nelfilcon A no soak / nelfilcon A soak
Nelfilcon A contact lenses inserted directly from the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
 Device: Nelfilcon A contact lens
Commercially marketed, single vision, soft contact lens for daily disposable wear
Other Name: Focus Dailies with AquaRelease

Device: FID 107027 solution
Commercially marketed solution for contact lens disinfection
Other Name: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution
Active Comparator: Etafilcon A soak / etafilcon A no soak
Etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by etafilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours.
 Device: Etafilcon A contact lens
Commercially marketed, single vision, soft contact lens for daily disposable wear
Other Name: 1-Day ACUVUE Moist

Device: FID 107027 solution
Commercially marketed solution for contact lens disinfection
Other Name: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution
Active Comparator: Etafilcon A no soak / etafilcon A soak
Etafilcon A contact lenses inserted directly from the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours.
 Device: Etafilcon A contact lens
Commercially marketed, single vision, soft contact lens for daily disposable wear
Other Name: 1-Day ACUVUE Moist

Device: FID 107027 solution
Commercially marketed solution for contact lens disinfection
Other Name: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution


Outcome Measures
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Primary Outcome Measures :
  1. Average Corneal Staining Area [ Time Frame: After 2 hours of wear ]
    Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together.

  2. Total Corneal Staining Type [ Time Frame: After 2 hours of wear ]
    Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed.


Secondary Outcome Measures :
  1. Ocular Comfort [ Time Frame: After 2 hours of wear ]
    Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes feel..." with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable.

  2. Ocular Redness [ Time Frame: After two hours of wear ]
    Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes look..." with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older.
  • Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
  • Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to study.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • History of hypersensitivity to any components of the multi-purpose solution.
  • Evidence or history of ocular conditions as prescribed in protocol.
  • One functional eye or a monofit lens
  • Any slit-lamp finding score equal to 1 at Visit 1 of each study period.
  • Significant corneal staining at visit 1 of each study period as prescribed in protocol.
  • Other protocol-defined exclusion criteria may apply.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733291


Locations
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United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00733291    
Other Study ID Numbers: MS-008
First Posted: August 13, 2008    Key Record Dates
Results First Posted: December 21, 2011
Last Update Posted: December 28, 2011
Last Verified: December 2011
Keywords provided by Alcon Research:
Daily disposable contact lenses
Multi-purpose disinfecting solutions
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases
Pharmaceutical Solutions