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

Not Applicable

Completed

• Conditions: Myopia; Contact Lens Comfort; Hyperopia

• Registration Number: NCT01684046
• Lead Sponsor: Alcon Research

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-10
• Study First Posted: 2012-09-12
• Study Start: 2012-11
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-03
• Results First Submitted: 2014-03-27
• Results First Submitted QC: 2014-03-27
• Last Update Submitted: 2014-03-27
• Results First Posted: 2014-04-29
• Last Update Posted: 2014-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Subjective Lens Wear Comfort	Day 30	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.