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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

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
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.

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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014