Trial Outcomes & Findings for Objective Testing of Tear Film Stability (NCT NCT00789529)

Results Overview

The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

2 weeks

Results posted on

2013-05-31

Participant Flow

Recruitment of patients was conducted by approaching the patients seen in the practice.

32 subjects were recruited and enrolled in the study. No subjects had to be excluded.

Participant milestones

Participant milestones
Measure	1 - ReNu MultiPlus First, Opti-Free RepleniSH Second Used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the first intervention period, and used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the second intervention period	2 - Opti-Free RepleniSH First, ReNu MultiPlus Second Used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the first intervention period, and used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the second intervention period
Overall Study STARTED	16	16
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	1 - ReNu MultiPlus First, Opti-Free RepleniSH Second Used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the first intervention period, and used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the second intervention period	2 - Opti-Free RepleniSH First, ReNu MultiPlus Second Used Opti-Free RepleniSH multi-purpose disinfecting solution for the care of new contact lenses in the first intervention period, and used ReNu MultiPlus multi-purpose solution for the care of new contact lenses in the second intervention period
Overall Study Withdrawal by Subject	0	1
Overall Study Other Reason	1	0

Baseline Characteristics

Objective Testing of Tear Film Stability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 - ReNu MultiPlus First n=16 Participants Used ReNu MultiPlus first, Opti-Free RepleniSH Second	2 - Opti-Free RepleniSH First n=16 Participants Opti-Free RepleniSH first, ReNu MultiPlus Second	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants	16 Participants n=4 Participants	32 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age Continuous	27.3 years STANDARD_DEVIATION 3.8 • n=93 Participants	27.4 years STANDARD_DEVIATION 5.1 • n=4 Participants	27.3 years STANDARD_DEVIATION 4.4 • n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	14 Participants n=4 Participants	27 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Region of Enrollment United States	16 participants n=93 Participants	16 participants n=4 Participants	32 participants n=27 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Per protocol. All participants that completed both arms were analysed.

The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.

Outcome measures

Outcome measures
Measure	Opti-Free® RepleniSH® MPDS n=30 Participants Used Opti-Free® RepleniSH® MPDS	Renu MultiPlus® n=30 Participants Used Renu MultiPlus®
Objective, In-vivo Soft Contact Lens Wettability Index	-1.82 wettability index Standard Deviation 2.88	-1.98 wettability index Standard Deviation 2.80

SECONDARY outcome

Timeframe: 2 weeks

Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale. 0=Very poor 50 = Excellent

Outcome measures

Outcome measures
Measure	Opti-Free® RepleniSH® MPDS n=30 Participants Used Opti-Free® RepleniSH® MPDS	Renu MultiPlus® n=30 Participants Used Renu MultiPlus®
Subject Questionnaire Response	42.7 units on a scale Standard Deviation 7.3	43.1 units on a scale Standard Deviation 5.0

Adverse Events

1 - ReNu MultiPlus First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 - Opti-Free RepleniSH First

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

Dr. George Zikos

Manhattan Vision Associates / Institute for Vision Research

Phone: 2126884277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60