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

NCT01684033 | Completed Results

• 2 other identifiers: M-12-0381941/ALC
• Study Type: interventional
• Target: 207
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia; Hyperopia; Contact Lens Comfort

Keywords

multi-purpose solution; silicone hydrogel; contact lenses; comfort; Opti-Free; Biotrue

Outcome Measures

Primary Outcomes (2)

• Corneal Staining

  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.

  Day 30

• Change From Baseline in Corneal Staining at 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.

  Baseline (Day 0), Day 30

Study Arms (2)

PureMoist - Biotrue

OTHER

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

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

Biotrue - PureMoist

OTHER

Biotrue™ MPS 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; Device: Biotrue™ MPS; Device: Habitual contact lenses

Interventions

Habitual contact lenses 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.

Biotrue - PureMoist; PureMoist - Biotrue

Opti-Free® PureMoist® MPDS DEVICE

Also known as: OPTI-FREE® PureMoist™

Biotrue - PureMoist; PureMoist - Biotrue

Biotrue™ MPS DEVICE

Also known as: Biotrue™

Biotrue - PureMoist; PureMoist - Biotrue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jessie Lemp, GMA Brand Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Jessie Lemp, MS

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: September 12, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 17, 2014
• Results First Posted: April 17, 2014

Record last verified: 2014-03