Trial Outcomes & Findings for Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers (NCT NCT01164865)

Last Updated: 2012-10-12

Results Overview

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."

Recruitment status

COMPLETED

Study phase

Target enrollment

78 participants

Primary outcome timeframe

Baseline (Day 0), 2 weeks

Results posted on

2012-10-12

Participant Flow

Participants were recruited from two US study centers.

Participant milestones

Participant milestones
Measure	OPTI-FREE RepleniSH OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.	Clear Care Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Overall Study STARTED	39	39
Overall Study COMPLETED	37	38
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	OPTI-FREE RepleniSH OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.	Clear Care Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OPTI-FREE RepleniSH n=39 Participants OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.	Clear Care n=39 Participants Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.	Total n=78 Participants Total of all reporting groups
Age Continuous	37.1 years STANDARD_DEVIATION 12.27 • n=5 Participants	41.5 years STANDARD_DEVIATION 9.59 • n=7 Participants	39.3 years STANDARD_DEVIATION 11.16 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	39 participants n=7 Participants	78 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), 2 weeks

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

Outcome measures

Outcome measures
Measure	OPTI-FREE RepleniSH n=37 Participants OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.	Clear Care n=38 Participants Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Change From Baseline in Ocular Comfort Rating at 2 Weeks	-8.20 Units on a scale Interval -13.84 to -2.55	-7.14 Units on a scale Interval -12.74 to -1.54

PRIMARY outcome

Timeframe: 2 weeks

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

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.

Outcome measures

Outcome measures
Measure	OPTI-FREE RepleniSH n=37 Participants OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.	Clear Care n=38 Participants Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
Likert Questionnaire Scores at 2 Weeks I can comfortably wear my lenses	4.20 Units on a scale Interval 3.96 to 4.44	4.24 Units on a scale Interval 4.0 to 4.48
Likert Questionnaire Scores at 2 Weeks My lenses stay moist from morning to evening	3.60 Units on a scale Interval 3.28 to 3.92	3.69 Units on a scale Interval 3.37 to 4.01
Likert Questionnaire Scores at 2 Weeks The solution I use feels gentle on my eyes	4.00 Units on a scale Interval 3.75 to 4.25	3.66 Units on a scale Interval 3.41 to 3.91
Likert Questionnaire Scores at 2 Weeks My lenses feel fresh	3.79 Units on a scale Interval 3.52 to 4.05	4.03 Units on a scale Interval 3.77 to 4.29
Likert Questionnaire Scores at 2 Weeks At the end of the day, my vision is clear	3.54 Units on a scale Interval 3.2 to 3.88	3.86 Units on a scale Interval 3.52 to 4.19
Likert Questionnaire Scores at 2 Weeks When I put my lenses in, they feel comfortable	4.05 Units on a scale Interval 3.78 to 4.33	4.03 Units on a scale Interval 3.76 to 4.3
Likert Questionnaire Scores at 2 Weeks I like the way this product feels during handling	4.09 Units on a scale Interval 3.84 to 4.34	3.66 Units on a scale Interval 3.42 to 3.91
Likert Questionnaire Scores at 2 Weeks My lenses feel moist	3.84 Units on a scale Interval 3.56 to 4.12	3.64 Units on a scale Interval 3.36 to 3.92

Adverse Events

OPTI-FREE RepleniSH

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clear Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jami Kern, Ph.D.

Alcon Global Medical Affairs

Phone: 1-888-451-3937

Results disclosure agreements

Principal investigator is a sponsor employee Alcon reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER