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Trial Outcomes & Findings for CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation (NCT NCT02147093)

NCT ID: NCT02147093

Last Updated: 2018-06-19

Results Overview

Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m\^2 and 2.5 cd/m\^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m\^2) High Contrast (90%) \& Low Contrast (10%) and Low Luminance (2.5 cd/m\^2) High Contrast (90%)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

7 days post wear

Results posted on

2018-06-19

Participant Flow

A total of 41 subjects were enrolled in this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 40 subjects were dispensed a study lens. Of the dispensed subjects, 3 were discontinued and 37 subjects completed the study.

Participant milestones

Participant milestones
Measure
Control (Filcon II 3- Sphere) /Test (Filcon II 3-multi-focal)
Subjects were first fitted with the Control lens (filcon II 3- sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (filcon II 3-multi-focal) for one week.
Test (Filcon II 3-multi-focal) /Control (Filcon II 3- Sphere)
Subjects were first fitted with the Test lens (filcon II 3-multi-focal) for one week. Subjects were then fitted with Control lens (filcon II 3- sphere) and a pair of reading glasses for one week.
Period 1
STARTED
20
20
Period 1
COMPLETED
20
19
Period 1
NOT COMPLETED
0
1
Period 2
STARTED
20
19
Period 2
COMPLETED
18
19
Period 2
NOT COMPLETED
2
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Control (Filcon II 3- Sphere) /Test (Filcon II 3-multi-focal)
Subjects were first fitted with the Control lens (filcon II 3- sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (filcon II 3-multi-focal) for one week.
Test (Filcon II 3-multi-focal) /Control (Filcon II 3- Sphere)
Subjects were first fitted with the Test lens (filcon II 3-multi-focal) for one week. Subjects were then fitted with Control lens (filcon II 3- sphere) and a pair of reading glasses for one week.
Period 1
Lost to Follow-up
0
1
Period 2
Protocol Violation
2
0

Baseline Characteristics

CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control (Filcon II 3-sphere) /Test (Filcon II 3-multi-focal)
n=20 Participants
All subjects that were randomized to sequence and were dispensed a study lens.
Test (Filcon II 3-multi-focal) / Control (Filcon II 3-spher)
n=20 Participants
All subjects that were randomized to sequence and were dispensed a study lens.
Total
n=40 Participants
Total of all reporting groups
Age, Continuous
56.20 years
STANDARD_DEVIATION 7.682 • n=5 Participants
58.00 years
STANDARD_DEVIATION 9.067 • n=7 Participants
56.78 years
STANDARD_DEVIATION 8.490 • n=5 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
12 Participants
n=7 Participants
26 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
8 Participants
n=7 Participants
14 Participants
n=5 Participants
Region of Enrollment
United Kingdom
20 participants
n=5 Participants
20 participants
n=7 Participants
40 participants
n=5 Participants

PRIMARY outcome

Timeframe: 7 days post wear

Population: All subjects that completed all study visits without a major protocol deviation.

Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m\^2 and 2.5 cd/m\^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m\^2) High Contrast (90%) \& Low Contrast (10%) and Low Luminance (2.5 cd/m\^2) High Contrast (90%)

Outcome measures

Outcome measures
Measure
Control (Filcon II 3-sphere)
n=37 Participants
Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
Test (Filcon II 3-multi-focal)
n=37 Participants
Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
Distance LogMAR Visual Acuity
High Contrast-Distance-Standard High Luminance
-0.466 LogMAR
Standard Deviation 0.9995
-0.972 LogMAR
Standard Deviation 1.0104
Distance LogMAR Visual Acuity
Low Contrast-Distance-Standard High Luminance
-2.842 LogMAR
Standard Deviation 1.6850
-3.768 LogMAR
Standard Deviation 1.8023
Distance LogMAR Visual Acuity
High Contrast-Distance-Standard Low Luminance
-2.834 LogMAR
Standard Deviation 1.0042
-3.700 LogMAR
Standard Deviation 0.8939

PRIMARY outcome

Timeframe: 7 days post wear

Population: All subjects that completed all study visits without a major protocol deviation.

Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m\^2 and 50 cd/m\^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m\^2) High Contrast (90%) \& Low Contrast (10%) and Low Luminance (50cd/m\^2) High Contrast (90%)

Outcome measures

Outcome measures
Measure
Control (Filcon II 3-sphere)
n=37 Participants
Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
Test (Filcon II 3-multi-focal)
n=37 Participants
Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
Near LogMAR Visual Acuity
High Contrast-Near-Standard High Luminance
-1.455 LogMAR
Standard Deviation 0.6309
-2.545 LogMAR
Standard Deviation 1.1240
Near LogMAR Visual Acuity
Low Contrast-Near-Standard High Luminance
-2.151 LogMAR
Standard Deviation 1.0221
-3.820 LogMAR
Standard Deviation 1.4124
Near LogMAR Visual Acuity
High Contrast-Near-Standard Low Luminance
-1.878 LogMAR
Standard Deviation 1.0546
-3.441 LogMAR
Standard Deviation 1.3941

Adverse Events

Control (Filcon II 3-sphere)

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

Test (Filcon II 3-multi-focal)

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

Tom Karkkainen, OD, MS, FAAO

Johnson & Johnson Vision Care INC.

Phone: 904-443-3500

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60