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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01164865
• Collaborator: (none)
• Enrollment: 78
• Arms: 2
• Duration (Months): 6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Wear	Device: OPTI-FREE RepleniSH multipurpose disinfecting solution; Device: Clear Care contact lens care system; Device: Contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: The Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OPTI-FREE RepleniSH 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; 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.; Other Names: OPTI-FREE® RepleniSH® ; Device: Contact lenses; 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.
Active Comparator: Clear Care 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; 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.; Other Names: Clear Care® ; Device: Contact lenses; 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.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Ocular Comfort Rating at 2 Weeks [Baseline (Day 0), 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."

2. Likert Questionnaire Scores at 2 Weeks [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01164865
• Other Study ID Numbers: SMA-09-58
• First Posted: Jul 19, 2010
• Last Update Posted: Oct 12, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by Alcon Research: Soft Contact lens; Multi-Purpose Solution; Hydrogen Peroxide

Study Results

Participant Flow

Recruitment Details	Participants were recruited from two US study centers.

Arm/Group Title	OPTI-FREE RepleniSH	Clear Care
Arm/Group Description	OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.	Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Period Title: Overall Study
STARTED	39	39
COMPLETED	37	38
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	OPTI-FREE RepleniSH	Clear Care	Total
Arm/Group Description	OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.	Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.	Total of all reporting groups
Overall Participants	39	39	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.1 (12.27)	41.5 (9.59)	39.3 (11.16)
Sex: Female, Male (Count of Participants)
Female	29 74.4%	26 66.7%	55 70.5%
Male	10 25.6%	13 33.3%	23 29.5%
Region of Enrollment (participants) [Number]
United States	39 100%	39 100%	78 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Ocular Comfort Rating at 2 Weeks
Description	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."
Time Frame	Baseline (Day 0), 2 weeks

Outcome Measure Data

Analysis Population Description

All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.

Arm/Group Title	OPTI-FREE RepleniSH	Clear Care
Arm/Group Description	OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.	Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Measure Participants	37	38
Least Squares Mean (95% Confidence Interval) [Units on a scale]	-8.20	-7.14

2. Primary Outcome

Title	Likert Questionnaire Scores at 2 Weeks
Description	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.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations.

Arm/Group Title	OPTI-FREE RepleniSH	Clear Care
Arm/Group Description	OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.	Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Measure Participants	37	38
I can comfortably wear my lenses	4.20	4.24
My lenses stay moist from morning to evening	3.60	3.69
The solution I use feels gentle on my eyes	4.00	3.66
My lenses feel fresh	3.79	4.03
At the end of the day, my vision is clear	3.54	3.86
When I put my lenses in, they feel comfortable	4.05	4.03
I like the way this product feels during handling	4.09	3.66
My lenses feel moist	3.84	3.64

Adverse Events

Time Frame	Adverse events were collected for the duration of the study: 5 months, 3 weeks.
Adverse Event Reporting Description	The safety population included all enrolled and exposed participants.
Arm/Group Title	OPTI-FREE RepleniSH		Clear Care
Arm/Group Description	OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.		Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
All Cause Mortality
	OPTI-FREE RepleniSH		Clear Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	OPTI-FREE RepleniSH		Clear Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	OPTI-FREE RepleniSH		Clear Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Alcon reserves the right of prior review of any publication or presentation of information related to the study.