Trial Outcomes & Findings for Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens (NCT NCT02886923)

NCT ID: NCT02886923

Last Updated: 2019-12-20

Results Overview

Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 250 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 15 minutes post lens fit
• Results posted on: 2019-12-20

Participant Flow

A total of 24 subjects were enrolled into this study. Of the enrolled subjects 23 were dispensed a study lens while 1 subject failed to meet all eligibility criteria. Of the dispensed subjects, all 23 completed the study.

Participant milestones

Measure	Hioxilfilcon A (Test)/ Hioxifilcon A (Control) Subjects that received the Test lens during the first study period and the Control lens during the second study period.	Hioxilfilcon A (Control)/ Hioxifilcon A (Test) Subjects that were received the Control lens during the first study period and the Test lens during the second stud period.
Period 1 STARTED	12	11
Period 1 COMPLETED	12	11
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	12	11
Period 2 COMPLETED	12	11
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens

Baseline characteristics by cohort

Measure	Dispensed Subjects n=23 Participants All subjects that were dispensed a study lens.
Age, Continuous	38.0 Years STANDARD_DEVIATION 2.57 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	5 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United Kingdom	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes post lens fit

Population: All subjects who had successfully completed all required visits without any protocol deviations that the study responsible clinician documented as impacting the assessment of the hypotheses.

Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 250 cd/m2 luminance. The luminance requirements were same at the target and at the eye.

Binocular functional visual performance was measured for the centrally presented high contrasts targets.

Outcome measures

Measure	Hioxifilcon A (Test) n=23 Participants Subjects that wore the Test lens in either the first or second period of the study.	Hioxifilcon A (Control) n=23 Participants Subjects that wore the Control lens in either the first or second period of the study.
The Binocular Functional Visual Performance Under Distance Day Time Conditions (250 cd/m2) for Centrally Presented High Contrasts (HC) Time Controlled Visual Acuity (TCVA) Targets.	-0.03 -10 x logMAR Standard Deviation 0.754	0.33 -10 x logMAR Standard Deviation 0.656

SECONDARY outcome

Timeframe: 15 Minutes post lens fitting

Population: All subjects who had successfully completed all required visits without any protocol deviations that the study responsible clinician documented as impacting the assessment of the hypotheses.

Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 2.5 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.

Outcome measures

Measure	Hioxifilcon A (Test) n=23 Participants Subjects that wore the Test lens in either the first or second period of the study.	Hioxifilcon A (Control) n=23 Participants Subjects that wore the Control lens in either the first or second period of the study.
The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets.	-2.16 -10 x logMAR Standard Deviation 0.606	-1.69 -10 x logMAR Standard Deviation 0.727

SECONDARY outcome

Timeframe: 15 Minutes post lens fitting

Population: All subjects who had successfully completed all required visits without any protocol deviations that the study responsible clinician documented as impacting the assessment of the hypotheses.

Time Controlled Visual Acuity (TCVA) was assessed at 67 cm using 50 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.

Outcome measures

Measure	Hioxifilcon A (Test) n=23 Participants Subjects that wore the Test lens in either the first or second period of the study.	Hioxifilcon A (Control) n=23 Participants Subjects that wore the Control lens in either the first or second period of the study.
The Binocular Functional Visual Performance Under Intermediate Vision Indoor Conditions (50 cd/m2) for Centrally Presented HC TCVA Targets.	-1.29 -10 x logMAR Standard Deviation 0.673	-1.04 -10 x logMAR Standard Deviation 0.782

Adverse Events

Hioxifilcon A (Test)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hioxifilcon A (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

Ross Franklin - PRINCIPAL RESEARCH OPTOMETRIST

Johnson & Johnson Vision

Phone: 904 4431768

Email: RFrankl1@its.jnj.com

Results disclosure agreements

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

Restriction type: GT60