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Trial Outcomes & Findings for Evaluation of Rotation With a Multifocal Toric Contact Lens (NCT NCT05433571)

NCT ID: NCT05433571

Last Updated: 2023-07-27

Results Overview

Absolute rotation was assessed for each subject eye using a slit lamp, at 1-, 3-, 7-, 15- and 25-minutes after lens insertion. However, absolute rotation at 15-minutes was the primary endpoint. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

15-minutes post lens insertion

Results posted on

2023-07-27

Participant Flow

A total of 102 subjects were enrolled in this study. Of those enrolled, all subjects were dispensed both lenses and completed the study. No subjects were discontinued.

Participant milestones

Participant milestones
Measure
Senofilcon A(C3) Toric Lens UV/HEV Filter(Low DC)/Senofilcon A(C3) Toric Lens UV/HEV Filter(High DC)
Subjects randomized to this sequence received the Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (Low DC) during the first period and then received the Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (High DC) during the second period
Senofilcon A(C3) Toric Lens UV/HEV Filter(High DC)/Senofilcon A(C3) Toric Lens UV/HEV Filter(Low DC)
Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (High DC) during the first period and then received the Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (Low DC) during the second period
Period 1
STARTED
53
49
Period 1
COMPLETED
53
49
Period 1
NOT COMPLETED
0
0
Period 2
STARTED
53
49
Period 2
COMPLETED
53
49
Period 2
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Rotation With a Multifocal Toric Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Total
n=102 Participants
Total Subjects
Age, Continuous
52.3 years
STANDARD_DEVIATION 8.11 • n=93 Participants
Sex: Female, Male
Female
81 Participants
n=93 Participants
Sex: Female, Male
Male
21 Participants
n=93 Participants
Race/Ethnicity, Customized
Asian
2 Participants
n=93 Participants
Race/Ethnicity, Customized
Black or African American
6 Participants
n=93 Participants
Race/Ethnicity, Customized
White
93 Participants
n=93 Participants
Race/Ethnicity, Customized
Other
1 Participants
n=93 Participants
Region of Enrollment
United States · participants
102 Participants
n=93 Participants

PRIMARY outcome

Timeframe: 15-minutes post lens insertion

Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.

Absolute rotation was assessed for each subject eye using a slit lamp, at 1-, 3-, 7-, 15- and 25-minutes after lens insertion. However, absolute rotation at 15-minutes was the primary endpoint. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.

Outcome measures

Outcome measures
Measure
Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (Low DC)
n=204 Eyes
Subjects that wore the Test lens Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (Low DC) in either the first or second period of the study.
Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (High DC)
n=204 Eyes
Subjects that wore the Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (High DC) in either the first or second period of the study.
Proportion of Eyes With Absolute Rotation ≤ 10 Degrees
0.9167 Proportion
0.8873 Proportion

Adverse Events

Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (Low C)

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

Senofilcon A (C3) Multifocal Toric Lens With UV/HEV Filter (High DC)

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

Ross Franklin

Johnson & Johnson Vision Care (JJVC)

Phone: 1-800-843-2020

Results disclosure agreements

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