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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00884806
First received: April 17, 2009
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Contact Lens Care
 Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
Device: Etafilcon A contact lens (ACUVUE® 2™)
Device: Senofilcon A contact lens (ACUVUE® OASYS™)
Device: Lotrafilcon B contact lens (O2 OPTIX®)
Device: Balafilcon A contact lens (PureVision®)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Corneal Staining Evaluation of SiH MPDS FID 114675A

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Solution-Related Corneal Staining [ Time Frame: Day 7 ] [ 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.


Secondary Outcome Measures:
  • Mean Lens Comfort [ Time Frame: Day 7 ] [ 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, "Over the previous 2-3 hours, my lenses felt comfortable," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.


Enrollment: 110
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FID 114675A
FID 114675A used for 7 days, per protocol-specified instructions. Silicone hydrogel or hydrogel contact lenses worn bilaterally on a daily wear basis, one brand only.
 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: Etafilcon A contact lens (ACUVUE® 2™)
Commercially marketed hydrogel contact lens for daily wear use
Other Name: ACUVUE® 2™
Device: Senofilcon A contact lens (ACUVUE® OASYS™)
Commercially marketed silicone hydrogel contact lens for daily wear use
Other Name: ACUVUE® OASYS™
Device: Lotrafilcon B contact lens (O2 OPTIX®)
Commercially marketed silicone hydrogel contact lens for daily wear use
Other Name: O2 OPTIX®
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.
  • 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00884806     History of Changes
Other Study ID Numbers: C-08-081
Study First Received: April 17, 2009
Results First Received: February 20, 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 May 23, 2013