Trial Outcomes & Findings for Marketed Contact Lens Real World Through Focus Curve (NCT NCT02679976)

NCT ID: NCT02679976

Last Updated: 2016-09-15

Results Overview

Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M\^2 ), Medium luminance ( 50 CD/M\^2 ) and High luminance ( 250 CD/M\^2 )

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 4 Hr. Post Fitting
• Results posted on: 2016-09-15

Participant Flow

A total of 30 subjects were enrolled into this study. Subjects were stratified as either Hyperope or Myopes using a 1:1 allocation. All enrolled subjects completed the study.

Participant milestones

Measure	Etafilcon A (Multi-focal) All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
Overall Study STARTED	30
Overall Study Hyperopes	16
Overall Study Myopes	14
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Marketed Contact Lens Real World Through Focus Curve

Baseline characteristics by cohort

Measure	Etafilcon A (Multi-focal) n=30 Participants All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
Age, Continuous	51.7 years STANDARD_DEVIATION 7.37 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	0 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	16 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants
Race/Ethnicity, Customized White	10 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants
Region of Enrollment United Kingdom	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 Hr. Post Fitting

Population: The analysis population includes all subjects that completed the study without a major protocol deviation.

Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )

Outcome measures

Measure	Etafilcon A (Multi-focal)- Hyperopes n=16 Participants All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.	Etafilcon A (Multi-focal)- Myopes n=14 Participants All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
Distance Binocular LogMAR Visual Acuity Low Luminance; N=16, N=14	-1.072 -10*LogMAR Standard Deviation 0.8748	-0.904 -10*LogMAR Standard Deviation 1.1423
Distance Binocular LogMAR Visual Acuity Medium Luminance; N=16, N=14	0.9017 -10*LogMAR Standard Deviation 0.450	0.557 -10*LogMAR Standard Deviation 0.9465
Distance Binocular LogMAR Visual Acuity High Luminance; N=16, N=14	1.488 -10*LogMAR Standard Deviation 0.6960	1.471 -10*LogMAR Standard Deviation 1.650

PRIMARY outcome

Timeframe: 4 Hr. Post Fitting

Population: The analysis population includes all subjects that completed the study without a major protocol deviation.

Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )

Outcome measures

Measure	Etafilcon A (Multi-focal)- Hyperopes n=16 Participants All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.	Etafilcon A (Multi-focal)- Myopes n=14 Participants All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
Near Binocular LogMAR Visual Acuity Low Luminance; N=16, N=14	-2.278 -10*LogMAR Standard Deviation 1.6989	-2.261 -10*LogMAR Standard Deviation 1.7030
Near Binocular LogMAR Visual Acuity Medium Luminance; N=16, N=14	-0.591 -10*LogMAR Standard Deviation 1.4003	-0.650 -10*LogMAR Standard Deviation 1.5274
Near Binocular LogMAR Visual Acuity High Luminance; N=16, N=14	0.828 -10*LogMAR Standard Deviation 0.9910	0.786 -10*LogMAR Standard Deviation 1.0480

PRIMARY outcome

Timeframe: 4 Hr. Post Fitting

Population: The analysis population includes all subjects that completed the study without a major protocol deviation.

intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )

Outcome measures

Measure	Etafilcon A (Multi-focal)- Hyperopes n=16 Participants All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.	Etafilcon A (Multi-focal)- Myopes n=14 Participants All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
Intermediate Binocular LogMAR Visual Acuity High Luminance; N=16, N=14	1.056 -10*LogMAR Standard Deviation 0.7616	1.157 -10*LogMAR Standard Deviation 0.7037
Intermediate Binocular LogMAR Visual Acuity Low Luminance; N=16, N=14	-1.544 -10*LogMAR Standard Deviation 1.0355	-1.318 -10*LogMAR Standard Deviation 1.4770
Intermediate Binocular LogMAR Visual Acuity Medium Luminance; N=16, N=14	-0.075 -10*LogMAR Standard Deviation 0.8367	0.043 -10*LogMAR Standard Deviation 1.1410

Adverse Events

Etafilcon A (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 SR. PRINCIPAL RESEARCH OPTOMETRIST

Johnson & Johnson Vision Care Inc.

Phone: 904-443-3500

Email: TKarkkai@its.jnj.com

Results disclosure agreements

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

Restriction type: GT60