Effect of an Investigational Multi-Purpose Solution on Lens Moisture

Effect of SiH MPDS FID 114675A vs. a Marketed Multi-Purpose Solution on Lens Moisture

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.

Study Overview

• Status: Completed
• Conditions: Contact Lens Moisture
• Intervention / Treatment: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: Silicone Hydrogel Contact Lenses; Device: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS)

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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: PureVision®; Acuvue® Oasys™
ACTIVE_COMPARATOR: ReNu MultiPlus; Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study 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: PureVision®; Acuvue® Oasys™; 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 Names: ReNu MultiPlus® Multi-Purpose Solution Fresh Lens Comfort™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Ex-Vivo Advancing Contact Angle	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.	Day 1, 8 hours
Mean Ex-Vivo Advancing Contact Angle	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.	Day 8, 16 hours

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Justin R Webb, OD, Alcon Research

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: December 9, 2009
• First Submitted That Met QC Criteria: April 25, 2011
• First Posted (ESTIMATE): April 26, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 13, 2012
• Last Update Submitted That Met QC Criteria: March 21, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Contact Lenses; Contact Lens Care; Multi-Purpose Solution
• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: C-09-031