Trial Outcomes & Findings for Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP) (NCT NCT01180777)

Results Overview

Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

95 participants

Primary outcome timeframe

10-15 minutes post lens fit

Results posted on

2018-06-19

Participant Flow

This study was an eight-site, randomized, 4-visit, bilateral crossover, dispensing trial.

Of those 95 enrolled subjects in this study, 3 did not meet the eligibility criteria, 6 prematurely discontinued from the study, and 6 excluded from the analysis due to protocol deviations.

Participant milestones

Participant milestones
Measure	All Subjects All subjects who enrolled, randomized, and exposed to the study lenses. Subjects where randomized to a study arm and wore all three of the study lenses by study completion. Randomization was to the arms as outlined in the 'arms' section of the protocol.
Overall Study STARTED	92
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	All Subjects All subjects who enrolled, randomized, and exposed to the study lenses. Subjects where randomized to a study arm and wore all three of the study lenses by study completion. Randomization was to the arms as outlined in the 'arms' section of the protocol.
Overall Study Protocol Violation	6
Overall Study Poor lens fit	4
Overall Study Lost to Follow-up	1
Overall Study Adverse Event	1

Baseline Characteristics

Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=95 Participants Subjects were to wear all three lenses over the course of the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	95 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	95 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	95 participants n=5 Participants

PRIMARY outcome

Timeframe: 10-15 minutes post lens fit

Population: All subjects who successfully completed the study.

Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.

Outcome measures

Outcome measures
Measure	Etafilcon A (A) n=158 Eyes Daily wear contact lens	Etafilcon A (B) n=160 Eyes Daily wear contact lens	Etafilcon A (C) n=157 Eyes Daily wear contact lens
Lens Fit Acceptance Acceptable	158 eyes	158 eyes	157 eyes
Lens Fit Acceptance Unacceptable	0 eyes	2 eyes	0 eyes

SECONDARY outcome

Timeframe: 10-15 minutes post lens fit

Population: All subjects who successfully completed the study.

Binocular Snellen VA was assessed at dispensing by Investigator using a Snellen vision chart. Subjects were analyzed based on their performance on a Snellen Vision chart exam in the study lenses in an effort to measure how well the lenses perform for vision correction.

Outcome measures

Outcome measures
Measure	Etafilcon A (A) n=78 Participants Daily wear contact lens	Etafilcon A (B) n=78 Participants Daily wear contact lens	Etafilcon A (C) n=78 Participants Daily wear contact lens
Binocular Snellen Visual Acuity (VA) 20/15	42 participants	39 participants	45 participants
Binocular Snellen Visual Acuity (VA) 20/20	36 participants	39 participants	33 participants

SECONDARY outcome

Timeframe: After 6-9 days of lens wear

Population: All subjects who successfully completed the study.

Corneal staining type was graded in a 5-point scale over the 5 corneal regions by Investigator using a slit lamp; 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Maximum grade of corneal staining type over the 5 corneal regions was categorized either absence or presence of corneal staining for the analysis.

Outcome measures

Outcome measures
Measure	Etafilcon A (A) n=160 eye Daily wear contact lens	Etafilcon A (B) n=154 eye Daily wear contact lens	Etafilcon A (C) n=158 eye Daily wear contact lens
Corneal Staining Central region grade > 0	4 eyes	6 eyes	3 eyes
Corneal Staining Inferior region grade > 0	34 eyes	25 eyes	44 eyes
Corneal Staining Nasal region grade > 0	2 eyes	6 eyes	7 eyes
Corneal Staining Superior region grade > 0	7 eyes	5 eyes	3 eyes
Corneal Staining Temporal region grade > 0	8 eyes	3 eyes	5 eyes

Adverse Events

All Subjects

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Subjects n=95 participants at risk Subjects were to wear all three lenses over the course of the study. Due to the non-ocular related AE, all subjects are summarized to report the occurrence of event.
Gastrointestinal disorders Appendicitis	1.1% 1/95 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Michael S. Mayers, O.D., FAAO

Johnson & Johnson Vision Care

Phone: 1-904-443-3252

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication requires agreement and written authorization from the Sponsor
Publication restrictions are in place

Restriction type: OTHER