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Effect of an Investigational Multi-Purpose Solution on Lens Moisture

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ClinicalTrials.gov Identifier: NCT01341990
Recruitment Status : Completed
First Posted : April 26, 2011
Results First Posted : April 13, 2012
Last Update Posted : April 13, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of the study is to evaluate the effect of an investigational multi-purpose disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of silicone hydrogel contact lenses.

Condition or disease Intervention/treatment Phase
Contact Lens Moisture Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS) Device: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS) Device: Silicone Hydrogel Contact Lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of SiH MPDS FID 114675A vs. a Marketed Multi-Purpose Solution on Lens Moisture
Study Start Date : November 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: FID 114675A
Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
Investigational solution intended for use as a cleaning, rinsing, reconditioning, disinfecting, and storage solution for silicone hydrogel and soft contact lenses

Device: Silicone Hydrogel Contact Lenses
Commercially marketed silicone hydrogel contact lenses per habitual prescription for daily wear use, at least 8 hours/day. New pair dispensed at Day 0 (Baseline Visit) and at the conclusion of Day 1 (Visit 2).
Other Names:
  • Acuvue® Oasys™
  • PureVision®

Active Comparator: ReNu MultiPlus
Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
Device: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS)
Commercially marketed prodouct indicated for cleaning, removing protein deposits, rinsing, disinfecting, and storing soft contact lenses
Other Name: ReNu MultiPlus® Multi-Purpose Solution Fresh Lens Comfort™

Device: Silicone Hydrogel Contact Lenses
Commercially marketed silicone hydrogel contact lenses per habitual prescription for daily wear use, at least 8 hours/day. New pair dispensed at Day 0 (Baseline Visit) and at the conclusion of Day 1 (Visit 2).
Other Names:
  • Acuvue® Oasys™
  • PureVision®




Primary Outcome Measures :
  1. Mean Ex-Vivo Advancing Contact Angle [ Time Frame: Day 1, 8 hours ]
    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.

  2. Mean Ex-Vivo Advancing Contact Angle [ Time Frame: Day 8, 16 hours ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older.
  • Wears silicone hydrogel contact lenses on a daily wear basis i.e. disinfects lenses every night).
  • Has successfully worn contact lenses for 5 days, 8 hours per day, prior to baseline visit.
  • Vision is correctable to 20/30 or better in each eye at distance with study lenses at baseline visit.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Known sensitivity or intolerance to contact lens multi-purpose solutions.
  • Use of any topical ocular OTC or prescribed topical ocular medications.
  • History or current ocular infections or ocular inflammatory events.
  • Ocular surgery within the past year.
  • Medical condition or use of medication that cause ocular side effects.
  • Participation in any investigational study within the past 30 days.
  • Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341990


Locations
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United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Justin R Webb, OD Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01341990     History of Changes
Other Study ID Numbers: C-09-031
First Posted: April 26, 2011    Key Record Dates
Results First Posted: April 13, 2012
Last Update Posted: April 13, 2012
Last Verified: March 2012
Keywords provided by Alcon Research:
Contact Lenses
Contact Lens Care
Multi-Purpose Solution
Additional relevant MeSH terms:
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Pharmaceutical Solutions