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Trial Outcomes & Findings for Evaluation of ACUVUE® OASYS 1-Day for Astigmatism Contact Lenses With Alternative Lidstock (NCT NCT05713552)

NCT ID: NCT05713552

Last Updated: 2024-03-05

Results Overview

Ocular symptoms were assessed using open-ended question. Investigators asked each subject if they experienced any eye symptoms or problems with lens wear when wearing the study lenses. If responded "Yes", then subject characterized each symptom to the following scale for each eye: 0 = Not Applicable or Not Recorded, 1 = Mild and results in little or no interference with lens wear, 2 = Moderate AND/OR occasionally interferes with lens wear, and 3 = Severe AND/OR frequently interferes with lens wear. Investigators classified each subject reported symptom into these categories: Burning/stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision, and Other. The data was dichotomized across all symptoms, where Y=1 if any "moderate" or "severe" ocular symptoms were reported and Y=0 otherwise. The proportion of eyes with any "moderate" or "severe" ocular symptoms was reported for each lens.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

Up to 1-Hour Follow-Up

Results posted on

2024-03-05

Participant Flow

A total of 31 subjects were enrolled in this study. Of those enrolled, 30 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, all 30 subjects completed the study.

Participant milestones

Participant milestones
Measure
Test/Control
Subjects randomized to receive the Test lens during the first period and the Control lens during the second period.
Control/Test
Subjects randomized to receive the Control lens during the first period and the Test lens during the second period.
Period 1
STARTED
15
15
Period 1
COMPLETED
15
15
Period 1
NOT COMPLETED
0
0
Period 2
STARTED
15
15
Period 2
COMPLETED
15
15
Period 2
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of ACUVUE® OASYS 1-Day for Astigmatism Contact Lenses With Alternative Lidstock

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dispensed Subjects
n=30 Participants
All subjects dispensed a study lens.
Age, Continuous
29.5 Years
STANDARD_DEVIATION 6.43 • n=5 Participants
Sex: Female, Male
Female
21 Participants
n=5 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
5 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
3 Participants
n=5 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
Race/Ethnicity, Customized
White
21 Participants
n=5 Participants
Region of Enrollment
United States
30 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 1-Hour Follow-Up

Population: All subjects that were dispensed at least one study lens.

Ocular symptoms were assessed using open-ended question. Investigators asked each subject if they experienced any eye symptoms or problems with lens wear when wearing the study lenses. If responded "Yes", then subject characterized each symptom to the following scale for each eye: 0 = Not Applicable or Not Recorded, 1 = Mild and results in little or no interference with lens wear, 2 = Moderate AND/OR occasionally interferes with lens wear, and 3 = Severe AND/OR frequently interferes with lens wear. Investigators classified each subject reported symptom into these categories: Burning/stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision, and Other. The data was dichotomized across all symptoms, where Y=1 if any "moderate" or "severe" ocular symptoms were reported and Y=0 otherwise. The proportion of eyes with any "moderate" or "severe" ocular symptoms was reported for each lens.

Outcome measures

Outcome measures
Measure
Test
n=60 Eyes
Subjects that wore the Test lens during either the first or second period of the study.
Control
n=60 Eyes
Subjects that wore the Control lens during either the first or second period of the study.
Proportion of Eyes With Moderate or Severe Subject-Reported Ocular Symptoms
15-Minute Follow-up
0 Proportion of eyes
0 Proportion of eyes
Proportion of Eyes With Moderate or Severe Subject-Reported Ocular Symptoms
1-Hour Follow-up
0 Proportion of eyes
0 Proportion of eyes

Adverse Events

Test

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

Control

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