Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1

Not Applicable

Completed

Interventions: Device: Opti-Free® PureMoist® MPDS
Device: Biotrue™ MPS
Device: Habitual contact lenses

Brief Summary: The purpose of this study was to evaluate the performance of Opti-Free® PureMoist® Multi-Purpose Disinfecting Solution (MPDS) compared to Biotrue™ Multipurpose Solution (MPS) in silicone hydrogel contact lens wearers.

Detailed Description: In this 2-period crossover study, eligible participants were randomized to either Opti-Free® PureMoist® Multi-Purpose Disinfecting Solution or Biotrue™ Multipurpose Solution 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.

Recruitment & Eligibility

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 one 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 two days during the study;
Must have habitually used a Biguanide preserved multi-purpose solution (other than Biotrue) 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 multipurpose solution such as daily or enzyme cleaners within the one 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.

Arm && Interventions

Group	Intervention	Description
PureMoist - Biotrue	Habitual contact lenses	Opti-Free® PureMoist® MPDS used first, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.
Biotrue - PureMoist	Biotrue™ MPS	Biotrue™ MPS used first, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
Biotrue - PureMoist	Habitual contact lenses	Biotrue™ MPS used first, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
PureMoist - Biotrue	Opti-Free® PureMoist® MPDS	Opti-Free® PureMoist® MPDS used first, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.
PureMoist - Biotrue	Biotrue™ MPS	Opti-Free® PureMoist® MPDS used first, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.
Biotrue - PureMoist	Opti-Free® PureMoist® MPDS	Biotrue™ MPS used first, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Corneal Staining at Day 30	Baseline (Day 0), Day 30	Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.
Corneal Staining	Day 30	Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.

Secondary Outcome Measures

Name	Time	Method