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Evaluation of Deposits on Contact Lenses Worn Daily Wear

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00725153
First received: July 28, 2008
Last updated: July 20, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study was to measure front surface deposits on contact lenses when worn for ten hours.


Condition Intervention
Refractive Error
 Device: Balafilcon A contact lenses (PureVision)
Device: Etafilcon A contact lenses (Acuvue2)

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Front Surface Lens Deposits [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    Film and discrete deposits were assessed with a slit-lamp after 10 hours of 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: 55
Study Start Date: March 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PureVision/Acuvue 2
PureVision contact lenses worn first, with Acuvue 2 contact lenses worn second. Both products worn for 10 hours each.
 Device: Balafilcon A contact lenses (PureVision)
Commercially marketed, soft contact lenses worn bilaterally for 10 hours
Other Name: PureVision
Device: Etafilcon A contact lenses (Acuvue2)
Commercially marketed, soft contact lenses worn bilaterally for 10 hours
Other Name: Acuvue2
Acuvue 2/PureVision
Acuvue 2 contact lenses worn first, with PureVision contact lenses worn second. Both products worn for 10 hours each.
 Device: Balafilcon A contact lenses (PureVision)
Commercially marketed, soft contact lenses worn bilaterally for 10 hours
Other Name: PureVision
Device: Etafilcon A contact lenses (Acuvue2)
Commercially marketed, soft contact lenses worn bilaterally for 10 hours
Other Name: Acuvue2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years 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 prior to enrollment in the study.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Evidence or history of keratitis (dendritic keratitis); viral disease of the cornea and/or conjunctiva; acute bacterial disease of the cornea and/or conjunctiva and/or eyelids; infection of the eye; and/or fungal disease of the eye.
  • One functional eye or a monofit lens.
  • Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis.
  • Any slit-lamp finding score of (1) at the Screening Visit as defined in protocol.
  • Use of concomitant topical ocular prescription or over-the-counter (OTC) ocular medications.
  • History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725153

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: NCT00725153     History of Changes
Other Study ID Numbers: MS-006
Study First Received: July 28, 2008
Results First Received: September 25, 2009
Last Updated: July 20, 2012
Health Authority: United Kingdom: Research Ethics Committee
United States: Institutional Review Board

Keywords provided by Alcon Research:
Contact lens deposits
Soft contact lenses
Myopia

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013