Effect of FID 114675A on Lens Wettability

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01342107
First received: January 7, 2011
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.


Condition Intervention
Contact Lens Wettability
Device: FID 114675A multi-purpose disinfecting solution (MPDS)
Device: Soft contact lens
Device: Blister pack solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Alcon Multi-Purpose Disinfecting Solution (MPDS) on Lens Wettability

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Lens Wettability [ Time Frame: 16 hours ] [ Designated as safety issue: No ]
    As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.


Enrollment: 66
Study Start Date: December 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FID 114675A
Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to one eye, with contact lens removed directly from the blister pack assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours.
Device: FID 114675A multi-purpose disinfecting solution (MPDS)
Investigational multi-purpose disinfecting solution intended for use as a cleaning, reconditioning, rinsing, disinfecting, and storage solution for silicone hydrogel and soft contact lenses.
Device: Soft contact lens
Soft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense.
Other Names:
  • Acuvue2
  • PureVision
  • Acuvue Oasys
Active Comparator: Blister Pack
Contact lens removed directly from the blister pack randomly assigned to one eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours.
Device: Soft contact lens
Soft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense.
Other Names:
  • Acuvue2
  • PureVision
  • Acuvue Oasys
Device: Blister pack solution
Commercially approved storage solution as found in the contact lens blister pack.
Other Names:
  • Acuvue2
  • PureVision
  • Acuvue Oasys

  Eligibility

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

Inclusion Criteria:

  • 18 years or age or older with normal eyes, other than correction for refractive error.
  • At least 5 days successful daily wear (minimum 8 hours per day) of PureVision®, Acuvue® Oasys™, or Acuvue® 2 contact lenses prior to Visit 1
  • Vision correctable to 20/30 (Snellen) or better in each eye at distance with lenses at Visit 1 (Day 0 - Baseline).
  • Grade 0 or Grade 1 wettability in both eyes after at least 15 minutes of lens wear at Visit 1 (Day 0 - Baseline).
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of the study.
  • Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
  • Use of products other than a multi-purpose solution or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to Visit 1 (Day 0 - Baseline).
  • Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Use of lens rewetting drops is acceptable.
  • History or current ocular infections or ocular inflammatory events.
  • Ocular surgery within the past year.
  • Participation in any investigational study within the past 30 days.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342107

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76314
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01342107     History of Changes
Other Study ID Numbers: C-10-024
Study First Received: January 7, 2011
Results First Received: March 21, 2012
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Contact Lenses
Contact Lens Care
Multi-Purpose Solution Wettability
Myopia

ClinicalTrials.gov processed this record on April 17, 2014