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
  Purpose

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.


Condition Intervention
Contact Lens Care
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®)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Wettability of Silicone Hydrogel Lenses With SiH MPDS FID 114675A vs. A Marketed Multi-Purpose Solution

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: March 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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®
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.
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00885092     History of Changes
Other Study ID Numbers: C-08-082
Study First Received: April 17, 2009
Results First Received: February 24, 2012
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Contact lenses
Disinfecting solutions

ClinicalTrials.gov processed this record on April 23, 2014