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Trial Outcomes & Findings for Comparison of Two Soft Bifocal Contact Lenses (NCT NCT00724945)

NCT ID: NCT00724945

Last Updated: 2015-05-21

Results Overview

This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values \>0.00 indicate vision poorer than ideal and values\<0.0 indicate vision greater than ideal

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

113 participants

Primary outcome timeframe

after 1 week of wear

Results posted on

2015-05-21

Participant Flow

Participant milestones

Participant milestones
Measure
Senofilcon A/Balafilcon A
senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second
Balafilcon A/Senofilcon A
balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
Period 1
STARTED
58
55
Period 1
COMPLETED
55
54
Period 1
NOT COMPLETED
3
1
Period 2
STARTED
55
54
Period 2
COMPLETED
51
54
Period 2
NOT COMPLETED
4
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Senofilcon A/Balafilcon A
senofilcon A multifocal contact lenses worn first, balafilcon A multifocal contact lenses worn second
Balafilcon A/Senofilcon A
balafilcon A multifocal contact lenses worn first/ senofilcon A multifocal contact lenses worn second
Period 1
non-compliance
1
0
Period 1
Adverse Event
1
1
Period 1
Lost to Follow-up
1
0
Period 2
lens comfort issue
3
0
Period 2
lens physiology issue
1
0

Baseline Characteristics

Comparison of Two Soft Bifocal Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=103 Participants
The reporting group for baseline characteristics includes all subjects that completed the study wearing contact lenses made from either senofilcon A or balafilcon A material. Excluded are 8 subjects that discontinued and 2 subjects dispensed lenses from outside study contact lens materials.
Age, Continuous
49.2 years
STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male
Female
87 Participants
n=5 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
Region of Enrollment
United States
103 participants
n=5 Participants

PRIMARY outcome

Timeframe: after 1 week of wear

Population: Analysis includes participants who completed the study per protocol.

This outcome measures vision while subjects are looking at objects in the distance and is measures in logMARs.logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values \>0.00 indicate vision poorer than ideal and values\<0.0 indicate vision greater than ideal

Outcome measures

Outcome measures
Measure
Senofilcon A
n=103 Participants
multifocal contact lens
Balafilcon A
n=103 Participants
multifocal contact lens
Distance Visual Acuity
-0.08591 logMAR units
Standard Error 0.008816
-0.10267 logMAR units
Standard Error 0.008855

PRIMARY outcome

Timeframe: after 1 week wear

This outcome measures vision while subjects are looking at objects near to them and is measured in logMARs. logMAR is the logarithm of the minimum angle of resolution.The ideal is 0.0 and represents 20/20 Snellen acuity.logMAR values \>0.00 indicate vision poorer than ideal and values\<0.0 indicate vision greater than ideal.

Outcome measures

Outcome measures
Measure
Senofilcon A
n=103 Participants
multifocal contact lens
Balafilcon A
n=103 Participants
multifocal contact lens
Near Visual Acuity
0.02711 logMAR units
Standard Error 0.008816
0.01933 logMAR units
Standard Error 0.008861

PRIMARY outcome

Timeframe: after 1 week wear

Subjects responded to "How would you rate the overall quality of vision with these study contact lenses" using the following scale: 1=poor, 2=fair, 3=good, 4=very good, 5=excellent.

Outcome measures

Outcome measures
Measure
Senofilcon A
n=103 Participants
multifocal contact lens
Balafilcon A
n=103 Participants
multifocal contact lens
Subject Vision
3.4594 Scores on a scale
Standard Error 0.09926
3.3853 Scores on a scale
Standard Error 0.09926

Adverse Events

Senofilcon A/Balafilcon A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Balafilcon A/Senofilcon A

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

Thomas Karkkainen OD

Vistakon

Phone: 904-443-3402

Results disclosure agreements

  • Principal investigator is a sponsor employee The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
  • Publication restrictions are in place

Restriction type: OTHER