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Evaluation of Deposits on Contact Lenses Worn Extended Wear

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00725530
First received: July 28, 2008
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Myopia
 Device: balafilcon A contact lens (PureVision)
Device: etafilcon A contact lens (Acuvue2)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)

Resource links provided by NLM:

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

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Front Surface Lens Deposits [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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).


Enrollment: 54
Study Start Date: March 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725530

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00725530     History of Changes
Other Study ID Numbers: MS-007
Study First Received: July 28, 2008
Results First Received: September 25, 2009
Last Updated: July 19, 2012
Health Authority: United States: Institutional Review Board
United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013