Trial Outcomes & Findings for A Multi-Center Investigation of Patient Acceptability of OPTI-FREE RepleniSH® Multi-Purpose Disinfecting Solution (MPDS) (NCT NCT00772707)

Results Overview

Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

114 participants

Primary outcome timeframe

Baseline (Day 0)

Results posted on

2012-09-07

Participant Flow

Participants were recruited from 6 US study sites.

Participant milestones

Participant milestones
Measure	Opti-Free Replenish Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
Overall Study STARTED	114
Overall Study COMPLETED	111
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Opti-Free Replenish Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
Overall Study Withdrawn	3

Baseline Characteristics

A Multi-Center Investigation of Patient Acceptability of OPTI-FREE RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Opti-Free Replenish n=114 Participants Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
Age Continuous	36 years n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment United States	114 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: 6 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), withdrawal (3), and missing responses (1).

Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.

Outcome measures

Outcome measures
Measure	Opti-Free Replenish n=108 Participants Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
Comfort Ratings at Baseline My lens is comfortable upon instillation	86 Percentage of Participants
Comfort Ratings at Baseline My lenses feel comfortable at the end of the day	59 Percentage of Participants
Comfort Ratings at Baseline My vision is clear at the end of the day	57 Percentage of Participants
Comfort Ratings at Baseline I am satisfied with my overall lens experience	81 Percentage of Participants

PRIMARY outcome

Timeframe: 30 days

Population: 5 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), and withdrawal (3).

Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.

Outcome measures

Outcome measures
Measure	Opti-Free Replenish n=109 Participants Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
Comfort Ratings at 30 Days My lenses feel comfortable at the end of the day	88 Percentage of Participants
Comfort Ratings at 30 Days My vision is clear at the end of the day	91 Percentage of Participants
Comfort Ratings at 30 Days I am satisfied with my overall lens experience	91 Percentage of Participants
Comfort Ratings at 30 Days Study product enhances wearing experience more	71 Percentage of Participants
Comfort Ratings at 30 Days I will continue to use the study solution after	81 Percentage of Participants
Comfort Ratings at 30 Days My lens is comfortable upon instillation	92 Percentage of Participants

Adverse Events

Opti-Free Replenish

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