Trial Outcomes & Findings for Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and Spectacles in Low Astigmats (NCT NCT05056870)

Last Updated: 2023-04-27

Results Overview

Visual Acuity was collected for each subject eye at distance (4 meter) using a Logarithm of Minimal Angle of Resolution (logMAR) visual acuity scale. This was evaluated under high luminance and high contrast conditions (HLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. A value of 0.0 logMAR is equivalent to 20/20 Snellen Visual Acuity. Lower values of visual acuity indicate better vision. The average logMAR Visual Acuity was reported for each lens type.

Recruitment status

COMPLETED

Study phase

Target enrollment

174 participants

Primary outcome timeframe

1-Week Follow-up

Results posted on

2023-04-27

Participant Flow

A total of 174 subjects were enrolled in this study. Of those enrolled, a total of 161 subjects were assigned to one of two wear sequences; while 13 subjects were screen failure and/or not assigned. Of the total assigned subjects, 151 subjects completed the study while, 10 subjects were discontinued from the study.

Participant milestones

Participant milestones
Measure	Test/Control Subjects that wore the Test lens during Period 1 and the Control lens during Period 2.	Control/Test Subjects that wore the Control lens during Period 1 and the Test lens during Period 2.
Period 1 STARTED	80	81
Period 1 COMPLETED	76	77
Period 1 NOT COMPLETED	4	4
Period 2 STARTED	76	77
Period 2 COMPLETED	74	77
Period 2 NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Test/Control Subjects that wore the Test lens during Period 1 and the Control lens during Period 2.	Control/Test Subjects that wore the Control lens during Period 1 and the Test lens during Period 2.
Period 1 Site COVID-19 Related	3	3
Period 1 Subject Withdrawn by PI due to Non Compliance to Protocol	0	1
Period 1 Subject No Longer Meets Eligibility Criteria	1	0
Period 2 COVID-19 Related	1	0
Period 2 Subject No Longer Meets Eligibility Criteria	1	0

Baseline Characteristics

Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and Spectacles in Low Astigmats

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=161 Participants Subjects that wore either Test lens or Control during the study.
Age, Continuous	27.9 years STANDARD_DEVIATION 5.43 • n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	122 Participants n=5 Participants
Race (NIH/OMB) More than one race	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	161 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. At least one observation was recorded.

Outcome measures

Outcome measures
Measure	Test (AO1DfA) n=308 eyes Subjects that wore the Test lens during the study.	Control (AO1D) n=304 eyes Subjects that wore the Control lens during the study.
High Luminance High Contrast Monocular Visual Acuity (LogMAR)	-0.126 logMAR Standard Deviation 0.0798	-0.028 logMAR Standard Deviation 0.1123

SECONDARY outcome

Timeframe: 1-Week Follow-up

Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. At least one observation was recorded.

CLUE Vision Score was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each lens type was reported.

Outcome measures

Outcome measures
Measure	Test (AO1DfA) n=154 Participants Subjects that wore the Test lens during the study.	Control (AO1D) n=152 Participants Subjects that wore the Control lens during the study.
CLUE Vision Score	69.39 units on a scale Standard Deviation 20.151	41.49 units on a scale Standard Deviation 28.139

SECONDARY outcome

Timeframe: 1-Week Follow-up

Population: All subjects that completed all study visits without a major protocol deviation.

Outcome measures

Outcome measures
Measure	Test (AO1DfA) n=302 eyes Subjects that wore the Test lens during the study.	Control (AO1D) n=302 eyes Subjects that wore the Control lens during the study.
High Luminance High Contrast Monocular Visual Acuity (LogMAR)	-0.128 logMAR Standard Deviation 0.0799	-0.107 logMAR Standard Deviation 0.0812

SECONDARY outcome

Timeframe: 1-Week Follow-up

Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from the study or deviation from the protocol. At least one observation was recorded.

Outcome measures

Outcome measures
Measure	Test (AO1DfA) n=151 Participants Subjects that wore the Test lens during the study.	Control (AO1D) Subjects that wore the Control lens during the study.
Subjective Contact Lens Preference Prefer Test	0.689 proportion of participants	—
Subjective Contact Lens Preference Prefer Control	0.225 proportion of participants	—
Subjective Contact Lens Preference No Preference	0.086 proportion of participants	—

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-Principal Research Optometrist

Johnson & Johnson Vision Care, Inc.

Phone: 1-800-843-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60