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OpenTrials
Completed

NCT Number: NCT00884806

7-Day, Multi-Site Study of an Investigational Multi-Purpose Disinfecting Solution for Contact Lens Wearers

The purpose of this study is to clinically evaluate solution-related corneal staining with an investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel contact lens wearers.

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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.
  • Wear contact lenses a minimum of 8 hours per day for at least 7-10 days prior to Visit 1 (screening visit).
  • Vision correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses at Visit 1.
  • Must discontinue contact lens wear for at least two consecutive days before Visit 2 (baseline visit).
  • Other protocol-specified 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 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

Etafilcon A contact lens (ACUVUE® 2™)

Device

Commercially marketed hydrogel contact lens for daily wear use

Other names: ACUVUE® 2™

Senofilcon A contact lens (ACUVUE® Oasys™)

Device

Commercially marketed silicone hydrogel contact lens for daily wear use

Other names: ACUVUE® OASYS™

Lotrafilcon B contact lens (O2 OPTIX®)

Device

Commercially marketed silicone hydrogel contact lens for daily wear use

Other names: O2 OPTIX®

Balafilcon A contact lens (PureVision®)

Device

Commercially marketed silicone hydrogel contact lens for daily wear use

Other names: PureVision®

Primary outcomes

  1. Solution-Related Corneal Staining

    Time frame: Day 7

    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.

Secondary outcomes

  1. Mean Lens Comfort

    Time frame: Day 7

    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, "Over the previous 2-3 hours, my lenses felt comfortable," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Corneal Staining Evaluation of SiH MPDS FID 114675A

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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