Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00885092
First received: April 17, 2009
Last updated: March 21, 2012
Last verified: March 2012

April 17, 2009
March 21, 2012
March 2009
May 2009   (final data collection date for primary outcome measure)
Mean Ex-Vivo Wetting Angle [ Time Frame: Day 7, Hour 14 ] [ Designated as safety issue: No ]
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
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Complete list of historical versions of study NCT00885092 on ClinicalTrials.gov Archive Site
  • Mean Lens Comfort [ Time Frame: Day 7, Hour 14 ] [ Designated as safety issue: No ]
    Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, "My lenses feel comfortable right now," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.
  • Percentage of Participants With Solution-Related Corneal Staining [ Time Frame: Day 7, Hour 14 ] [ Designated as safety issue: No ]
    Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes and is reported as a percentage of total participants.
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Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution
Wettability of Silicone Hydrogel Lenses With SiH MPDS FID 114675A vs. A Marketed Multi-Purpose Solution

The purpose of this study is to clinically evaluate an investigational multi-purpose disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of silicone hydrogel contact lenses.

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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Contact Lens Care
  • Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
    Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses.
  • Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)
    Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses.
    Other Name: (OPTI-FREE® RepleniSH®)
  • Device: Senofilcon A contact lens (ACUVUE® Oasys™)
    Commercially marketed silicone hydrogel contact lens for daily wear use
    Other Name: ACUVUE® Oasys™
  • Device: Balafilcon A contact lens (PureVision®)
    Commercially marketed silicone hydrogel contact lens for daily wear use
    Other Name: PureVision®
  • FID 114675A / RepleniSH
    FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
    Interventions:
    • Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
    • Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)
    • Device: Senofilcon A contact lens (ACUVUE® Oasys™)
    • Device: Balafilcon A contact lens (PureVision®)
  • RepleniSH / FID 114675A
    RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
    Interventions:
    • Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
    • Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)
    • Device: Senofilcon A contact lens (ACUVUE® Oasys™)
    • Device: Balafilcon A contact lens (PureVision®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older.
  • Must be successfully wearing assigned study lens brand (either ACUVUE® OASYS™ or PureVision® contact lenses) for at least 7-10 days, minimum 8 hours a day, prior to Visit 1 (screening).
  • Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1 (screening).
  • Must have discontinued contact lens wear for at least two consecutive days before Visit 2 (baseline).
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study.
  • Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products).
  • Monocular vision (only one eye with functional vision) or fit with only one contact lens.
  • Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit.
  • Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator.
  • Any corneal surgery, cataract surgery, intraocular lens implants or glaucoma filtering surgery within the last 12 months.
  • Any slit-lamp finding score of 1 (or rated 3 or 4 for limbal and bulbar conjunctival injection) at screening or baseline visits.
  • Corneal staining area assessment ≥ 20% in any corneal region in either eye at screening or baseline visit.
  • Corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye at baseline visit.
  • Participation in any investigational clinical study within 30 days of baseline visit.
  • Other protocol-defined exclusion criteria may apply.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00885092
C-08-082
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
March 2012

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