Trial Outcomes & Findings for Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers (NCT NCT01211535)

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." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

Baseline (Day 0), Day 14

Results posted on

2012-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	OPTI-FREE RepleniSH OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days	ReNu Biotrue ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
Overall Study STARTED	52	52
Overall Study COMPLETED	52	51
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	OPTI-FREE RepleniSH OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days	ReNu Biotrue ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
Overall Study Adverse Event	0	1

Baseline Characteristics

Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OPTI-FREE RepleniSH n=52 Participants OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days	ReNu Biotrue n=52 Participants ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days	Total n=104 Participants Total of all reporting groups
Age Continuous	33.3 years STANDARD_DEVIATION 10.4 • n=93 Participants	35.4 years STANDARD_DEVIATION 10.96 • n=4 Participants	34.3 years STANDARD_DEVIATION 10.71 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	10 Participants n=4 Participants	24 Participants n=27 Participants
Sex: Female, Male Male	38 Participants n=93 Participants	42 Participants n=4 Participants	80 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 14

Population: All participants who received regimen, satisfied inclusion/exclusion criteria, and completed the 14-day treatment period (per protocol)

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." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.

Outcome measures

Outcome measures
Measure	OPTI-FREE RepleniSH n=52 Participants OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days	ReNu Biotrue n=51 Participants ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 Baseline (Day 0)	87.40 Units on a scale Interval 83.82 to 90.99	88.79 Units on a scale Interval 85.21 to 92.37
Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 Day 14	81.75 Units on a scale Interval 78.17 to 85.33	83.18 Units on a scale Interval 79.56 to 86.79
Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 Change from Baseline (Day 0) at Day 14	-5.65 Units on a scale Interval -10.72 to -0.59	-5.61 Units on a scale Interval -10.7 to -0.52

Adverse Events

OPTI-FREE RepleniSH

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ReNu Biotrue

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
Publication restrictions are in place

Restriction type: OTHER