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Trial Outcomes & Findings for Clinical Evaluation of Two Daily Disposable Toric Soft Contact Lenses Over One Week of Wear (NCT NCT05291936)

NCT ID: NCT05291936

Last Updated: 2023-06-06

Results Overview

Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

78 participants

Primary outcome timeframe

Up to 1-Week Follow-up

Results posted on

2023-06-06

Participant Flow

A total of 78 subjects were enrolled in this study. Of those enrolled, 73 subjects were dispensed at least one study lens, while 5 subjects failed to meet all eligibility criteria. Of those dispensed, 69 subjects completed the study while 4 subjects were discontinued.

Participant milestones

Participant milestones
Measure
Verofilcon A/Stenfilcon A
Subjects randomized to receive the verofilcon A lens during period 1 and the stenfilcon A lens during period 2.
Stenfilcon A/Verofilcon A
Subjects randomized to receive the stenfilcon A lens during period 1 and the verofilcon A lens during period 2.
Period 1
STARTED
36
37
Period 1
COMPLETED
35
36
Period 1
NOT COMPLETED
1
1
Period 2
STARTED
35
36
Period 2
COMPLETED
34
35
Period 2
NOT COMPLETED
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Verofilcon A/Stenfilcon A
Subjects randomized to receive the verofilcon A lens during period 1 and the stenfilcon A lens during period 2.
Stenfilcon A/Verofilcon A
Subjects randomized to receive the stenfilcon A lens during period 1 and the verofilcon A lens during period 2.
Period 1
Unsatisfactory Visual Response due to Test Article
0
1
Period 1
Withdrew Consent during study
1
0
Period 2
Adverse Event
0
1
Period 2
Unsatisfactory Visual Response due to Test Article
1
0

Baseline Characteristics

Clinical Evaluation of Two Daily Disposable Toric Soft Contact Lenses Over One Week of Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dispensed Subjects
n=73 Participants
All subjects dispensed a study lens.
Age, Continuous
28.9 Years
STANDARD_DEVIATION 5.33 • n=5 Participants
Sex: Female, Male
Female
48 Participants
n=5 Participants
Sex: Female, Male
Male
25 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
3 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
7 Participants
n=5 Participants
Race/Ethnicity, Customized
White
62 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
1 Participants
n=5 Participants
Region of Enrollment
United States
73 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 1-Week Follow-up

Population: All dispensed subjects regardless of subsequent withdrawal from study or deviation from protocol.

Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported.

Outcome measures

Outcome measures
Measure
Verofilcon A
n=144 Eyes
Subjects that wore the verofilcon A lens during either the first or second period of the study.
Stenfilcon A
n=144 Eyes
Subjects that wore the stenfilcon A lens during either the first or second period of the study.
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
0 Proportion of eyes
0 Proportion of eyes

Adverse Events

Verofilcon A

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

Stenfilcon 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

Benjamin Straker

Johnson & Johnson Vision Care, Inc.

Phone: 1-800-843-2020

Results disclosure agreements

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

Restriction type: GT60