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

• 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.

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.

• 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®)

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.