Trial Outcomes & Findings for Comparison of a Silicone Hydrogel Daily Disposable Multifocal Contact Lens to a Marketed Product (NCT NCT05258149)

NCT ID: NCT05258149

Last Updated: 2023-05-19

Results Overview

Clarity of vision in dim or low lighting was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision in dim or low lighting conditions. This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 143 participants
• Primary outcome timeframe: 1-Week Follow-up
• Results posted on: 2023-05-19

Participant Flow

A total of 143 subjects were enrolled in this study. Of those enrolled, all 143 subjects were dispensed at least one study lens. Of those dispensed, 138 subjects completed the study while 5 subjects were discontinued.

Participant milestones

Measure	Senofilcon A C3/Delefilcon A/Delefilcon A Subjects in this sequence were randomized to receive the senofilcon A C3 lens during the first period and the delefilcon A lens during the second and third periods.	Delefilcon A/Senofilcon A C3/Senofilcon A C3 Subjects in this sequence were randomized to receive the delefilcon A lens during the first period and the senofilcon A C3 lens during the second and third periods.
Period 1 STARTED	70	73
Period 1 COMPLETED	69	72
Period 1 NOT COMPLETED	1	1
Period 2 STARTED	69	72
Period 2 COMPLETED	68	71
Period 2 NOT COMPLETED	1	1
Period 3 STARTED	68	71
Period 3 COMPLETED	68	70
Period 3 NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Senofilcon A C3/Delefilcon A/Delefilcon A Subjects in this sequence were randomized to receive the senofilcon A C3 lens during the first period and the delefilcon A lens during the second and third periods.	Delefilcon A/Senofilcon A C3/Senofilcon A C3 Subjects in this sequence were randomized to receive the delefilcon A lens during the first period and the senofilcon A C3 lens during the second and third periods.
Period 1 Protocol Deviation	1	0
Period 1 Adverse Event	0	1
Period 2 Unsatisfactory Visual Response due to Test Article	1	0
Period 2 Subject No Longer Meets Eligibility Criteria	0	1
Period 3 Subject Was Not Returning for More Than A Week	0	1

Baseline Characteristics

Comparison of a Silicone Hydrogel Daily Disposable Multifocal Contact Lens to a Marketed Product

Baseline characteristics by cohort

Measure	Hyperopes n=56 Participants Subjects were classified as Hyperopic if the distance spherical equivalent refraction was in the range of +0.75 D to +3.25 D.	Myopes n=87 Participants Subjects were classified as Myopic if the distance spherical equivalent refraction was in the range of -5.75 D to -1.25 D.	Total n=143 Participants Total of all reporting groups
Age, Continuous	57.3 Years STANDARD_DEVIATION 6.41 • n=5 Participants	49.0 Years STANDARD_DEVIATION 5.84 • n=7 Participants	52.3 Years STANDARD_DEVIATION 7.29 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	69 Participants n=7 Participants	114 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	18 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	51 Participants n=5 Participants	72 Participants n=7 Participants	123 Participants n=5 Participants
Region of Enrollment United States	56 Participants n=5 Participants	87 Participants n=7 Participants	143 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol and completion status.

Clarity of vision in dim or low lighting was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision in dim or low lighting conditions. This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.

Outcome measures

Measure	Senofilcon A C3 n=210 Observations Subjects that wore the senofilcon A C3 lens during any of the three study periods.	Delefilcon A n=208 Observations Subjects that wore the delefilcon A lens during any of the three study periods.
Clarity of Vision in Dim or Low Lighting Fair or Poor	12.4 Percent	20.6 Percent
Clarity of Vision in Dim or Low Lighting Excellent or Very Good	54.3 Percent	43.3 Percent
Clarity of Vision in Dim or Low Lighting Good	33.3 Percent	36.1 Percent

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol and completion status.

Clarity of vision when reading in dim light was assessed at the 1-week follow-up during each study period using the individual item: Clarity of vision when reading in dim light(e.g., menu or bill in a restaurant). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.

Outcome measures

Measure	Senofilcon A C3 n=210 Observations Subjects that wore the senofilcon A C3 lens during any of the three study periods.	Delefilcon A n=208 Observations Subjects that wore the delefilcon A lens during any of the three study periods.
Clarity of Vision When Reading in Dim Light Excellent or Very Good	46.2 Percent	32.2 Percent
Clarity of Vision When Reading in Dim Light Good	32.4 Percent	34.1 Percent
Clarity of Vision When Reading in Dim Light Fair or Poor	21.4 Percent	33.6 Percent

SECONDARY outcome

Timeframe: 1-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol and completion status.

Clarity of Distance vision was assessed at the 1-week follow-up during each study period using the individual item: Clarity of distance vision (i.e., looking at things that are more than 5 feet away, such as street signs). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B- Excellent and Very Good, Middle Box-Good and B2B- Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.

Outcome measures

Measure	Senofilcon A C3 n=210 Observations Subjects that wore the senofilcon A C3 lens during any of the three study periods.	Delefilcon A n=208 Observations Subjects that wore the delefilcon A lens during any of the three study periods.
Clarity of Distance Vision Excellent or Very Good	70.4 Percent	74.1 Percent
Clarity of Distance Vision Good	21.9 Percent	21.6 Percent
Clarity of Distance Vision Fair or Poor	7.7 Percent	4.3 Percent

SECONDARY outcome

Timeframe: 1-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol and completion status.

Clarity of Intermediate vision was assessed at the 1-week follow-up during each study period using the individual item: Clarity of intermediate vision (i.e., looking at things 2-3 feet away, such as your computer screen). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.

Outcome measures

Measure	Senofilcon A C3 n=210 Observations Subjects that wore the senofilcon A C3 lens during any of the three study periods.	Delefilcon A n=208 Observations Subjects that wore the delefilcon A lens during any of the three study periods.
Clarity of Intermediate Vision Excellent or Very Good	75.2 Percent	64.4 Percent
Clarity of Intermediate Vision Good	21.0 Percent	27.9 Percent
Clarity of Intermediate Vision Fair or Poor	3.8 Percent	7.7 Percent

SECONDARY outcome

Timeframe: 1-Week Follow-up

Population: All dispensed subjects regardless of deviation from protocol and completion status.

Clarity of Near vision was assessed at the 1-week follow-up during each study period using the individual item: Clarity of intermediate vision (i.e., looking at things close up, such as reading a book). This item used a 5-point like-rt scale of (1=Excellent, 2=Very good, 3=Good, 4=Fair and 5=Poor). Results were presented as the percentage of subjects' responses in each category by lens. For analysis and summary purposes three categories were used (T2B-Excellent and Very Good, Middle Box-Good and B2B-Fair and Poor). The 1-week follow-up from each study period (1, 2 and 3) were all included in the summary.

Outcome measures

Measure	Senofilcon A C3 n=210 Observations Subjects that wore the senofilcon A C3 lens during any of the three study periods.	Delefilcon A n=208 Observations Subjects that wore the delefilcon A lens during any of the three study periods.
Clarity of Near Vision Excellent or Very Good	52.3 Percent	38.0 Percent
Clarity of Near Vision Good	35.7 Percent	35.1 Percent
Clarity of Near Vision Fair or Poor	12 Percent	26.9 Percent

Adverse Events

Senofilcon A C3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delefilcon 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 R. Karkkainen, OD, MS, FAAO

Johnson & Johnson Vision Care, Inc.

Phone: 1-800-843-2020

Email: TKarkkai@its.jnj.com

Results disclosure agreements

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

Restriction type: GT60