Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers

NCT01164865 | Completed Results

• 1 other identifier: SMA-09-58
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to assess comfort in soft contact lens wearers.

Conditions

Contact Lens Wear

Keywords

Soft Contact lens; Multi-Purpose Solution; Hydrogen Peroxide

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Ocular Comfort Rating at 2 Weeks

  Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described "how your eyes feel right now."

  Baseline (Day 0), 2 weeks

• Likert Questionnaire Scores at 2 Weeks

  The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree.

  2 weeks

Study Arms (2)

OPTI-FREE RepleniSH

EXPERIMENTAL

OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.

Device: OPTI-FREE RepleniSH multipurpose disinfecting solution; Device: Contact lenses

Clear Care

ACTIVE COMPARATOR

Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.

Device: Clear Care contact lens care system; Device: Contact lenses

Interventions

OPTI-FREE RepleniSH multipurpose disinfecting solution DEVICE

FDA-approved, multipurpose disinfecting solution used according to provided instructions for cleaning, rinsing, storing, and disinfecting study contact lenses on a daily basis, 2 weeks.

Also known as: OPTI-FREE® RepleniSH®

OPTI-FREE RepleniSH

Clear Care contact lens care system DEVICE

FDA-approved, hydrogen peroxide-based, lens care system used according to provided instructions for cleaning, disinfecting, daily protein removing, and storage of study contact lenses on a daily basis, 2 weeks.

Also known as: Clear Care®

Clear Care

Contact lenses DEVICE

Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.

Clear Care; OPTI-FREE RepleniSH

Eligibility Criteria

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

You may qualify if:

• Wear silicone hydrogel contact lenses on a daily wear basis;
• Currently using OPTI-FREE RepleniSH contact lens solution;
• Report comfort above 75 on a Visual Analog Scale at the Baseline Visit;
• Read, sign, and date IRB-approved informed consent and the privacy document;
• Be generally healthy and have normal ocular health;
• Be be willing to follow the study procedures and visit schedule;

You may not qualify if:

• Use of additional lens cleaners;
• Known sensitivity to any ingredient in either of the test articles;
• Systemic or ocular disease or disorder (except refractive error) that would negatively affect the conduct or outcome of the study;
• Prior (within 7 days of enrollment) or current ocular infections;
• Clinically significant lash or lid abnormality;
• History of ocular surgery/trauma within the last 6 months;
• Use of any topical ocular or systemic antibiotics or corticosteroids within 7 days of enrollment;
• Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Interventions

Contact Lenses

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Jami Kern, Ph.D.
• Organization: Alcon Global Medical Affairs

1-888-451-3937

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 19, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 12, 2012
• Results First Posted: October 12, 2012

Record last verified: 2012-09