Trial Outcomes & Findings for Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers (NCT NCT01187355)

Results Overview

As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

591 participants

Primary outcome timeframe

Day 30

Results posted on

2012-07-30

Participant Flow

Subjects were recruited and enrolled from 42 US study centers.

The Participant Flow Chart includes all randomized patients: 591. Baseline characteristics are presented for all subjects who received test article and had at least one on-regimen study visit: 578.

Participant milestones

Participant milestones
Measure	Alcon MPDS Multi-purpose disinfecting contact lens solution	Renu Fresh MPS Multi-purpose contact lens solution
Overall Study STARTED	294	297
Overall Study COMPLETED	276	277
Overall Study NOT COMPLETED	18	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alcon MPDS n=288 Participants Multi-purpose disinfecting contact lens solution	Renu Fresh MPS n=290 Participants Multi-purpose contact lens solution	Total n=578 Participants Total of all reporting groups
Age Continuous	34.5 years STANDARD_DEVIATION 11.43 • n=5 Participants	34.0 years STANDARD_DEVIATION 11.24 • n=7 Participants	34.3 years STANDARD_DEVIATION 11.33 • n=5 Participants
Sex: Female, Male Female	209 Participants n=5 Participants	212 Participants n=7 Participants	421 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants	78 Participants n=7 Participants	157 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30

Population: All enrolled and dispensed subjects with an on-regimen follow-up visit.

As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.

Outcome measures

Outcome measures
Measure	Alcon MPDS n=276 Participants Multi-purpose disinfecting contact lens solution	Renu Fresh MPS n=277 Participants Multi-purpose contact lens solution
Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.	3.9 Units on a scale Standard Deviation 0.92	3.8 Units on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: Day 30

Population: All enrolled and dispensed subjects with an on-regimen follow-up visit.

As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.

Outcome measures

Outcome measures
Measure	Alcon MPDS n=276 Participants Multi-purpose disinfecting contact lens solution	Renu Fresh MPS n=276 Participants Multi-purpose contact lens solution
Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.	3.3 Units on a scale Standard Deviation 1.12	3.2 Units on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: Day 30

Population: All enrolled and dispensed subjects with an on-regimen follow-up visit.

As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.

Outcome measures

Outcome measures
Measure	Alcon MPDS n=276 Participants Multi-purpose disinfecting contact lens solution	Renu Fresh MPS n=277 Participants Multi-purpose contact lens solution
Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.	3.2 Units on a scale Standard Deviation 1.13	3.1 Units on a scale Standard Deviation 1.15

Adverse Events

Alcon MPDS

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Renu Fresh MPS

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Alcon MPDS n=292 participants at risk Multi-purpose disinfecting contact lens solution	Renu Fresh MPS n=297 participants at risk Multi-purpose contact lens solution
Psychiatric disorders Schizoaffective Disorder Bipolar Type	0.34% 1/292 • Number of events 1 • Adverse events were collected for the duration of the study: 5 months, 2 weeks, 1 day. This reporting group includes all subjects enrolled and dispensed test article.	0.00% 0/297 • Adverse events were collected for the duration of the study: 5 months, 2 weeks, 1 day. This reporting group includes all subjects enrolled and dispensed test article.
Reproductive system and breast disorders Abortion Spontaneous	0.00% 0/292 • Adverse events were collected for the duration of the study: 5 months, 2 weeks, 1 day. This reporting group includes all subjects enrolled and dispensed test article.	0.34% 1/297 • Number of events 1 • Adverse events were collected for the duration of the study: 5 months, 2 weeks, 1 day. This reporting group includes all subjects enrolled and dispensed test article.

Other adverse events

Adverse event data not reported

Additional Information

Director of Alcon Clinical

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor 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