Trial Outcomes & Findings for Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision Correction of Presbyopia (NCT NCT04073186)

Last Updated: 2022-08-10

Results Overview

Vision Scores were 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

91 participants

Primary outcome timeframe

2-Week Follow-up

Results posted on

2022-08-10

Participant Flow

A total of 91 subjects were enrolled in this study. Of those enrolled, 86 subjects were dispensed a least one study lens while 5 subjects failed to meet all eligibility criteria. Of those dispensed, 79 subjects completed the study, while 7 were discontinued.

Participant milestones

Participant milestones
Measure	Test Subjects received the Test lens throughout the study. Subjects wore the Test lens twice for a period of approximately 2 weeks each.
First Wearing Cycle STARTED	86
First Wearing Cycle COMPLETED	80
First Wearing Cycle NOT COMPLETED	6
Second Wearing Cycle STARTED	80
Second Wearing Cycle COMPLETED	79
Second Wearing Cycle NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Subjects received the Test lens throughout the study. Subjects wore the Test lens twice for a period of approximately 2 weeks each.
First Wearing Cycle Time required to complete last two study visits exceeds study deadline	1
First Wearing Cycle Withdrawal by Subject	1
First Wearing Cycle Protocol Violation	1
First Wearing Cycle Lens Discomfort	2
First Wearing Cycle Unsatisfactory Visual Response due to Test Article	1
Second Wearing Cycle Adverse Event	1

Baseline Characteristics

Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision Correction of Presbyopia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test n=86 Participants Subjects received the Test lens throughout the study. Subjects wore the Test lens twice for a period of approximately 2 weeks each.
Age, Continuous	54.8 Years STANDARD_DEVIATION 6.24 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	67 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	86 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2-Week Follow-up

Population: Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.

Outcome measures

Outcome measures
Measure	Test (First Wearing Cycle) n=76 Participants All subjects that wore the Test lens during the first wearing cycle	Test (Second Wearing Cycle) n=76 Participants All subjects that wore the Test lens during the second wearing cycle
Vision Scores	59.38 Units on a Scale Standard Deviation 19.700	56.19 Units on a Scale Standard Deviation 23.387

PRIMARY outcome

Timeframe: 2-Week Follow-up

Population: Subjects that completed all study visits without a major prtocol deviation impacting a primary endpoint

Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be etween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.

Outcome measures

Outcome measures
Measure	Test (First Wearing Cycle) n=76 Participants All subjects that wore the Test lens during the first wearing cycle	Test (Second Wearing Cycle) n=76 Participants All subjects that wore the Test lens during the second wearing cycle
Visual Performance (logMAR) Distance (4 Meter)	-0.08 logMAR Standard Deviation 0.097	-0.08 logMAR Standard Deviation 0.100
Visual Performance (logMAR) Intermediate (64 CM)	-0.02 logMAR Standard Deviation 0.096	-0.03 logMAR Standard Deviation 0.095
Visual Performance (logMAR) Near (40 CM)	0.04 logMAR Standard Deviation 0.085	0.02 logMAR Standard Deviation 0.081

SECONDARY outcome

Timeframe: Up to 2-Week Follow-up

Population: Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.

Vision Scores wwere 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.

Outcome measures

Outcome measures
Measure	Test (First Wearing Cycle) n=76 Participants All subjects that wore the Test lens during the first wearing cycle	Test (Second Wearing Cycle) n=76 Participants All subjects that wore the Test lens during the second wearing cycle
CLUE Vision Comparison Between First Wearing Cycle and Second Wearing Cycle	59.38 Units on a Scale Standard Deviation 19.700	56.19 Units on a Scale Standard Deviation 23.387

Adverse Events

Test

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Test n=86 participants at risk Subjects received the Test lens throughout the study. Subjects wore the Test lens twice for a period of approximately 2 weeks each.
Cardiac disorders Chest Pain	1.2% 1/86 • Number of events 1 • Throughout the entire duration of the study. Approximately 1 month per subject.

Other adverse events

Adverse event data not reported

Additional Information

Thomas Karkkainen- Sr. Principal Research Optometrist

Johnson & Johnson Vision Care

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