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Trial Outcomes & Findings for Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light (NCT NCT05344560)

NCT ID: NCT05344560

Last Updated: 2023-09-15

Results Overview

Subjective comfort was assessed using Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (Comfort, Vision, Handling, and Packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution where scores range from 0 to 120 with a population average score of 60 (SD 20). Higher CLUE scores indicate a more favorable/positive response. The average CLUE comfort score was report for each lens type.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

126 participants

Primary outcome timeframe

1-Week Follow-up

Results posted on

2023-09-15

Participant Flow

A total of 126 subjects were enrolled in this study. Of those enrolled, all 126 subjects were dispensed at least one study lens. Of those dispensed, 119 subjects completed the study while 7 subjects were discontinued.

Participant milestones

Participant milestones
Measure
Test\Control\Control
Subjects in this sequence were randomized to receive the Test \[senofilcon A (C3) HEV chromophore\] lens during the first period and the Control \[senofilcon A (C3)\] lens during the second and third periods .
Control\Test\Test
Subjects in this sequence were randomized to receive the Control \[senofilcon A (C3)\] lens during the first period and the Test \[senofilcon A (C3) HEV chromophore\] lens during the second and third periods.
Period 1
STARTED
63
63
Period 1
COMPLETED
62
62
Period 1
NOT COMPLETED
1
1
Period 2
STARTED
62
62
Period 2
COMPLETED
59
61
Period 2
NOT COMPLETED
3
1
Period 3
STARTED
59
61
Period 3
COMPLETED
58
61
Period 3
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Test\Control\Control
Subjects in this sequence were randomized to receive the Test \[senofilcon A (C3) HEV chromophore\] lens during the first period and the Control \[senofilcon A (C3)\] lens during the second and third periods .
Control\Test\Test
Subjects in this sequence were randomized to receive the Control \[senofilcon A (C3)\] lens during the first period and the Test \[senofilcon A (C3) HEV chromophore\] lens during the second and third periods.
Period 1
Subject out of visit window
1
1
Period 2
Covid-19 Related
1
0
Period 2
Adverse Event
1
0
Period 2
Subject out of visit window
1
1
Period 3
Subject out of visit window
1
0

Baseline Characteristics

Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dispensed Subjects
n=126 Participants
All subjects dispensed at least one study lens.
Age, Continuous
29.4 Years
STANDARD_DEVIATION 5.86 • n=5 Participants
Sex: Female, Male
Female
85 Participants
n=5 Participants
Sex: Female, Male
Male
41 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
3 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
11 Participants
n=5 Participants
Race/Ethnicity, Customized
White
111 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
1 Participants
n=5 Participants
Region of Enrollment
United States
126 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.

Subjective comfort was assessed using Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (Comfort, Vision, Handling, and Packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution where scores range from 0 to 120 with a population average score of 60 (SD 20). Higher CLUE scores indicate a more favorable/positive response. The average CLUE comfort score was report for each lens type.

Outcome measures

Outcome measures
Measure
Test [Senofilcon A (C3) HEV Chromophore]
n=119 Participants
Subjects that wore the Test \[senofilcon A (C3) HEV chromophore\] lens during any of the three study periods.
Control [Senofilcon A (C3)]
n=119 Participants
Subjects that wore the Control \[senofilcon A (C3)\] lens during any of the three study periods.
CLUE Comfort Score
63.50 Units on a scale
Standard Deviation 19.581
65.28 Units on a scale
Standard Deviation 20.915

Adverse Events

Test [Senofilcon A (C3) HEV Chromophore]

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

Control [Senofilcon A (C3)]

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

Benjamin Straker

Johnson & Johnson Vision Care, Inc. (JJVC)

Phone: 1-800-843-2020

Results disclosure agreements

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

Restriction type: GT60