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

NCT ID: NCT01684046

Last Updated: 2014-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-03-31

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.

Conditions

Myopia; Hyperopia; Contact Lens Comfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

Opti-Free® PureMoist® MPDS

Intervention Type: DEVICE

RevitaLens MPDS

Intervention Type: DEVICE

Habitual Contact Lenses

Intervention Type: DEVICE

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.

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.

Group Type: OTHER

Opti-Free® PureMoist® MPDS

Intervention Type: DEVICE

RevitaLens MPDS

Intervention Type: DEVICE

Habitual Contact Lenses

Intervention Type: DEVICE

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.

Interventions

Opti-Free® PureMoist® MPDS

Intervention Type: DEVICE

RevitaLens MPDS

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

OPTI-FREE® PureMoist®; RevitaLens OcuTec®; COMPLETE® RevitaLens

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessie Lemp, MS

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

M-12-041

Identifier Type: -

Identifier Source: org_study_id