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Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
University of Waterloo
ClinicalTrials.gov Identifier:
NCT00754338
First received: September 17, 2008
Last updated: September 28, 2010
Last verified: September 2010

September 17, 2008
September 28, 2010
January 2008
July 2008   (final data collection date for primary outcome measure)
  • Comfort [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.
  • Lens Wettability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).
  • Lens Deposits [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).
  • Comfort [ Time Frame: For each arm of the study: over the study period ] [ Designated as safety issue: No ]
  • Wettability [ Time Frame: At 2 and 4 week visits for each arm of the study ] [ Designated as safety issue: No ]
  • Protein and lipid deposition [ Time Frame: At 4 week visit for each arm of the study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00754338 on ClinicalTrials.gov Archive Site
  • Dryness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.
  • Subjective Vision [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.
  • Corneal Staining [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

    Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent.

    Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions.

    A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining.

  • Dryness [ Time Frame: For each arm of the study: over the study period ] [ Designated as safety issue: No ]
  • Subjective vision [ Time Frame: For each arm of the study: over the study period ] [ Designated as safety issue: No ]
  • Corneal staining [ Time Frame: At 2 and 4 week visits for each arm of the study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens
Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Ametropia
  • Drug: Alcon Opti-Free® RepleniSH® with Supraclens®
    Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover
    Other Name: Alcon Opti-Free® RepleniSH® with Supraclens®
  • Drug: Alcon Opti-Free® RepleniSH®
    Marketed Multipurpose Disinfecting Care System
    Other Name: Alcon Opti-Free® RepleniSH®
  • Drug: B&L ReNu MultiPlus™
    Marketed Multipurpose Disinfecting Care Systems
    Other Name: B&L ReNu MultiPlus™
  • Active Comparator: Phase1 - Arm 1
    Interventions:
    • Drug: Alcon Opti-Free® RepleniSH® with Supraclens®
    • Drug: Alcon Opti-Free® RepleniSH®
  • Active Comparator: Phase1 - Arm 2
    Interventions:
    • Drug: Alcon Opti-Free® RepleniSH® with Supraclens®
    • Drug: Alcon Opti-Free® RepleniSH®
  • Active Comparator: Phase 2 - Arm 1
    Interventions:
    • Drug: Alcon Opti-Free® RepleniSH® with Supraclens®
    • Drug: B&L ReNu MultiPlus™
  • Active Comparator: Phase 2 - Arm 2
    Interventions:
    • Drug: Alcon Opti-Free® RepleniSH® with Supraclens®
    • Drug: B&L ReNu MultiPlus™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
September 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is at least 17 years of age and has full legal capacity to volunteer.
  • Has read, understood and signed an information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
  • Has clear corneas and no active ocular disease.
  • Has had an ocular examination in the last two years.
  • Is a current soft lens wearer, replacing their lenses every two weeks to one month.
  • Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens.
  • Has astigmatism less than or equal to -1.00 DC.

Exclusion Criteria:

  • Has any signs or symptoms of dry eye.
  • Has any clinically significant blepharitis.
  • Has undergone corneal refractive surgery.
  • Is aphakic.
  • Has any active ocular disease.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that may affect ocular health.
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  • Is pregnant or lactating.
  • Is participating in any other type of clinical or research study.
  • Currently wears daily disposable lenses.
  • Currently wears lenses on an extended wear basis.
Both
17 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00754338
P/279/07/L
No
Desmond Fonn, MOptom., Centre for Contact Lens Research
University of Waterloo
Alcon Research
Study Chair: Desmond Fonn, MOptom University of Waterloo
University of Waterloo
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP