Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2

The purpose of this study was to evaluate the performance of Opti-Free® PureMoist® Multi-purpose Disinfecting Solution (MPDS) compared to AMO RevitaLens OcuTec® MPDS (US brand name)/COMPLETE RevitaLens (Europe brand name) in silicone hydrogel contact lens wearers.

Study Overview

• Status: Completed
• Conditions: Myopia; Hyperopia; Contact Lens Comfort
• Intervention / Treatment: Device: Opti-Free® PureMoist® MPDS; Device: RevitaLens MPDS; Device: Habitual Contact Lenses

Detailed Description

In this 2-period crossover study, eligible participants were randomized to either Opti-Free® PureMoist MPDS or RevitaLens MPDS in Period 1 for use with their habitual contact lenses, after which they switched to the alternate solution in Period 2. Each period was 30 days in length. A 2-day washout period during which participants refrained from using a multi-purpose contact lens solution preceded Period 1 and Period 2.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

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:

• Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®, Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least 1 month prior to Visit 1;
• Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on 2 days during the study;
• Must have habitually used a biguanide preserved multi-purpose solution (other than RevitaLens) for at least 30 days prior to Visit 1;
• Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses at Visit 1;
• Have access, capability and willingness to review and answer text messages;
• Read, sign, and date IRB/IEC approved informed consent and privacy document before enrollment;
• Willing to follow the study procedures and visit schedule;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Need to wear lenses on an extended wear (i.e overnight) basis during the study;
• Known sensitivity or intolerance to biguanide, polyquaternium-1 (POLYQUAD), or ALDOX preserved lens care products;
• Monocular (only one eye with functional vision) or fit with only one lens;
• Wearing toric or multifocal contact lenses or fit with monovision;
• Use of additional lens care products other than a biguanide preserved multi-purpose solution such as daily or enzyme cleaners within the 1 week prior to Visit 1;
• Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;
• Abnormal ocular condition observed during the Visit 1 slit-lamp examination;
• Current or history of ocular infections or severe inflammation within 6 months prior to Visit 1;
• Ocular surgery within the 12 months prior to Visit 1;
• Participation in any other clinical trial within 30 days of enrollment;
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: PureMoist - RevitaLens; Opti-Free® PureMoist® MPDS used first, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.	Device: Opti-Free® PureMoist® MPDS; Other Names: OPTI-FREE® PureMoist®; Device: RevitaLens MPDS; Other Names: RevitaLens OcuTec®; COMPLETE® RevitaLens; Device: Habitual Contact Lenses; Silicone hydrogel contact lenses per participant's habitual brand, prescription, and replacement schedule worn on a daily wear basis for at least 8 hours a day, 5 days a week for the duration of the study. During the washout period, the contact lenses were worn on a daily disposable basis.
OTHER: RevitaLens - PureMoist; RevitaLens MPDS used first, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.	Device: Opti-Free® PureMoist® MPDS; Other Names: OPTI-FREE® PureMoist®; Device: RevitaLens MPDS; Other Names: RevitaLens OcuTec®; COMPLETE® RevitaLens; Device: Habitual Contact Lenses; Silicone hydrogel contact lenses per participant's habitual brand, prescription, and replacement schedule worn on a daily wear basis for at least 8 hours a day, 5 days a week for the duration of the study. During the washout period, the contact lenses were worn on a daily disposable basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Lens Wear Comfort	Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, "When I use this solution, I can comfortably wear my lenses," with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.	Day 30

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: September 10, 2012
• First Submitted That Met QC Criteria: September 10, 2012
• First Posted (ESTIMATE): September 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 29, 2014
• Last Update Submitted That Met QC Criteria: March 27, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: comfort; contact lenses; silicone hydrogel; multi-purpose solution; Opti-Free; RevitaLens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: M-12-041