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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014