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

Alcon

Status: Completed

Conditions: Myopia; Hyperopia; Contact Lens Comfort

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01684033

M-12-038

1941/ALC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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207 participants in 2 patient groups

PureMoist - Biotrue

Other group

Description:

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

Treatment:

Device: Opti-Free® PureMoist® MPDS

Device: Habitual contact lenses

Device: Biotrue™ MPS

Biotrue - PureMoist

Other group

Description:

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

Treatment:

Device: Opti-Free® PureMoist® MPDS

Device: Habitual contact lenses

Device: Biotrue™ MPS