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OpenTrials
Completed

NCT Number: NCT00885092

Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution 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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FID 114675A multi-purpose disinfecting solution (MPDS)

Device

Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses.

RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)

Device

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 names: (OPTI-FREE® RepleniSH®)

Senofilcon A contact lens (ACUVUE® Oasys™)

Device

Commercially marketed silicone hydrogel contact lens for daily wear use

Other names: ACUVUE® Oasys™

Balafilcon A contact lens (PureVision®)

Device

Commercially marketed silicone hydrogel contact lens for daily wear use

Other names: PureVision®

Primary outcomes

  1. Mean Ex-Vivo Wetting Angle

    Time frame: Day 7, Hour 14

    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 outcomes

  1. Mean Lens Comfort

    Time frame: Day 7, Hour 14

    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.

  2. Percentage of Participants With Solution-Related Corneal Staining

    Time frame: Day 7, Hour 14

    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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Wettability of Silicone Hydrogel Lenses With SiH MPDS FID 114675A vs. A Marketed Multi-Purpose Solution

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 21, 2009
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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