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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Myopia, Hyperopia, Contact Lens Comfort

Intervention / Treatment
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* Device: Opti-Free® PureMoist® MPDS
* Device: RevitaLens MPDS
* Device: Habitual Contact Lenses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PureMoist - RevitaLens<br>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<br> <br> * Other names: OPTI-FREE® PureMoist®;Device: RevitaLens MPDS<br> <br> * Other names: COMPLETE® RevitaLens;Device: Habitual Contact Lenses<br>* 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.<br>|
| Other: RevitaLens - PureMoist<br>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<br> <br> * Other names: OPTI-FREE® PureMoist®;Device: RevitaLens MPDS<br> <br> * Other names: COMPLETE® RevitaLens;Device: Habitual Contact Lenses<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multi-purpose solution, silicone hydrogel, contact lenses, comfort, Opti-Free, RevitaLens