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Evaluation of Deposits on Contact Lenses Worn Extended Wear

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ClinicalTrials.gov Identifier: NCT00725530
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : August 22, 2012
Last Update Posted : August 22, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days.

Condition or disease Intervention/treatment Phase
Myopia Device: balafilcon A contact lens (PureVision) Device: etafilcon A contact lens (Acuvue2) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Study Start Date : March 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: balafilcon A / etafilcon A
Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
Device: balafilcon A contact lens (PureVision)
Commercially marketed, silicone hydrogel contact lens
Other Name: PureVision
Device: etafilcon A contact lens (Acuvue2)
Commercially marketed, hydrogel contact lens
Other Name: Acuvue2
Active Comparator: etafilcon A / balafilcon A
Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
Device: balafilcon A contact lens (PureVision)
Commercially marketed, silicone hydrogel contact lens
Other Name: PureVision
Device: etafilcon A contact lens (Acuvue2)
Commercially marketed, hydrogel contact lens
Other Name: Acuvue2



Primary Outcome Measures :
  1. Front Surface Lens Deposits [ Time Frame: 7 days ]
    Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying >25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits <2 (less than grade 2 for both film and discrete) and into front surface lens deposits >1 (greater than grade 1 for either film, discrete, or both).



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

Inclusion Criteria:

  • Age 18 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.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Evidence or history of ocular conditions as prescribed in the protocol.
  • One functional eye or a monofit lens.
  • Any slit-lamp finding score of (1) at the Screening Visit as defined by the protocol.
  • Use of concomitant topical ocular prescription or over-the-counter ocular medications.
  • History of seasonal allergies with significant ocular side effects.
  • Other protocol-defined exclusion criteria may apply.

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): NCT00725530


Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00725530     History of Changes
Other Study ID Numbers: MS-007
First Posted: July 30, 2008    Key Record Dates
Results First Posted: August 22, 2012
Last Update Posted: August 22, 2012
Last Verified: July 2012

Keywords provided by Alcon Research:
Lens deposits
Soft contact lens wearers