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Trial Outcomes & Findings for Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses (NCT NCT03755882)

NCT ID: NCT03755882

Last Updated: 2020-02-05

Results Overview

Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

46 participants

Primary outcome timeframe

Up to 2-Week Follow-up

Results posted on

2020-02-05

Participant Flow

A total of 46 subjects were enrolled into this study. Of those enrolled 45 were dispensed at least 1 study lens. Of those dispensed, 41 subjects completed the study while 4 were discontinued.

Participant milestones

Participant milestones
Measure
Test/Control
Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period
Control/Test
Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
Period 1
STARTED
23
22
Period 1
COMPLETED
19
22
Period 1
NOT COMPLETED
4
0
Period 2
STARTED
19
22
Period 2
COMPLETED
19
22
Period 2
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Test/Control
Subjects randomized to this sequence received the Test lens during the first period and then received the Control lens during the second period
Control/Test
Subjects randomized to this sequence received the Control lens during the first period and then received the Test lens during the second period
Period 1
Protocol Violation
1
0
Period 1
Unsatisfactory Lens Fitting Test Article
3
0

Baseline Characteristics

Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Total
n=45 Participants
All subjects dispensed a study lens
Age, Continuous
23.6 years
STANDARD_DEVIATION 2.80 • n=5 Participants
Sex: Female, Male
Female
45 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
45 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 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
China
45 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 2-Week Follow-up

Population: All subjects who had successfully completed all visits.

Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain 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 (Etafilcon A)
n=90 Eyes
Subjects that wore the Test lens in either the first or second period of the study.
Control (Hefilcon A)
n=82 Eyes
Subjects that wore the Control lens in either the first or second period of the study.
Visual Performance
High Luminnance Low Contrast
0.40 logMAR Units
Standard Deviation 0.074
0.38 logMAR Units
Standard Deviation 0.086
Visual Performance
High Luminance High Contrast
-0.09 logMAR Units
Standard Deviation 0.053
-0.10 logMAR Units
Standard Deviation 0.059
Visual Performance
Low Luminance High Contrast with Distance Goggles
-0.10 logMAR Units
Standard Deviation 0.055
-0.09 logMAR Units
Standard Deviation 0.055

Adverse Events

Test (Etafilcon A)

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

Control (Hefilcon 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

Brian Pall, OD, MS, FAAO- Director of clinical Sciences

Johnson & Johnson Vision Care Inc.

Phone: 904 443-1290

Results disclosure agreements

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

Restriction type: GT60