Trial Outcomes & Findings for Evaluation of Electronic LogMar Visual Acuity and Contrast Sensitivity in a Population of Contact Lens Wearers (NCT NCT03222037)

Results Overview

Visual Acuity was collected electronically under two conditions (high luminance low contrast and low luminance high contrast) in both eyes 15- minutes post study article administration. The average visual acuity for each lens type and condition was reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

49 participants

Primary outcome timeframe

15 Minutes post Treatment Administration

Results posted on

2019-09-10

Participant Flow

A total of 49 subjects were enrolled into this study. Of the enrolled subjects, 43 were dispensed at least one study article. Of the dispensed subjects all 43 completed the study.

Participant milestones

Participant milestones
Measure	Test/SCR Subjects that were randomized to receive the Test lens during the first period and then the SCR (Subjective Spherorcylindrical Refraction) treatment during the second period.	SCR/Test Subjects that were randomized to receive the SCR (Subjective Spherorcylindrical Refraction) treatment during the first period and then the Test lens during the second period.
Period 1 STARTED	21	22
Period 1 COMPLETED	21	22
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	21	22
Period 2 COMPLETED	21	22
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Electronic LogMar Visual Acuity and Contrast Sensitivity in a Population of Contact Lens Wearers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Dispensed n=43 Participants All subjects dispensed at least one study treatment.
Age, Continuous	26.8 Years STANDARD_DEVIATION 4.65 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian	8 Count of Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 Count of Participants n=5 Participants
Race/Ethnicity, Customized White	29 Count of Participants n=5 Participants
Region of Enrollment United States	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 Minutes post Treatment Administration

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

Visual Acuity was collected electronically under two conditions (high luminance low contrast and low luminance high contrast) in both eyes 15- minutes post study article administration. The average visual acuity for each lens type and condition was reported.

Outcome measures

Outcome measures
Measure	Test n=86 Eyes Subjects that received the Test lens during either the first or second period of the study.	SCR (Subjective Spherorcylindrical Refraction) n=86 Eyes Subjects that received the SCR treatment during either the first or second period of the study.
Visual Acuity (logMAR) High Luminance Low Contrast	0.15 logMAR Standard Deviation 0.108	0.21 logMAR Standard Deviation 0.130
Visual Acuity (logMAR) Low Luminance high Contrast	0.02 logMAR Standard Deviation 0.097	0.05 logMAR Standard Deviation 0.102

SECONDARY outcome

Timeframe: 15 minutes post treatment administration

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

Contrast sensitivity was assessed in both eyes at 1.5, 3.0, 6.0, 12.5 and 18.0 cycles per degrees (cpd) using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patients responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd.

Outcome measures

Outcome measures
Measure	Test n=86 Eyes Subjects that received the Test lens during either the first or second period of the study.	SCR (Subjective Spherorcylindrical Refraction) n=86 Eyes Subjects that received the SCR treatment during either the first or second period of the study.
Area Under Contrast Sensitivity Function Curve	1.39 log Standard Deviation 0.135	1.34 log Standard Deviation 0.185

Adverse Events

Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SCR (Subjective Spherorcylindrical Refraction)

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

Chantal Coles-Brennan -PRINCIPAL RESEARCH OPTOMETRIST

Johnson & Johnson Vision Care, INC.

Phone: 1-904-443-3449

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60