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
  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:


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
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: 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 July 29, 2014