Trial Outcomes & Findings for Clinical Evaluation of An Approved Contact Lens (NCT NCT02760810)

Results Overview

Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

2-Week Follow-up

Results posted on

2017-07-11

Participant Flow

A total of 31 subjects were enrolled in this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 30 were dispensed the study lens. Of the dispensed subjects 29 completed the study and 1 subject was discontinued from the study.

Participant milestones

Participant milestones
Measure	Narafilcon A All subjects wore the same lens throughout the study.
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Narafilcon A All subjects wore the same lens throughout the study.
Overall Study Protocol Violation	1

Baseline Characteristics

Clinical Evaluation of An Approved Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Narafilcon A n=30 Participants All subjects wore the same lens throughout the study.
Age, Continuous	22.8 Years STANDARD_DEVIATION 4.08 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized Asian	18 Participants n=5 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants
Region of Enrollment United Kingdom	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2-Week Follow-up

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

Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing

Outcome measures

Outcome measures
Measure	Narafilcon A n=54 Eyes All subjects wore the same lens throughout the study.
Tear Film Osmolarity	293.4 mOsm/L Standard Deviation 9.50

SECONDARY outcome

Timeframe: 1-Week Follow-up

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

Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing.

Outcome measures

Outcome measures
Measure	Narafilcon A n=54 Eyes All subjects wore the same lens throughout the study.
Tear Film Osmolarity	294.4 mOsm/L Standard Deviation 9.48

SECONDARY outcome

Timeframe: 1-Week Follow-up

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

Tear Film PH was measured using a 1mm Microglass electrode (Thermo Scientific Orion 9810BN) placed gently in lower temporal tear meniscus of non-Schirmer eye without simulating reflex tearing.

Outcome measures

Outcome measures
Measure	Narafilcon A n=27 Participants All subjects wore the same lens throughout the study.
Tear Film PH	6.86 PH value Standard Deviation 0.180

Adverse Events

Narafilcon 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

Andrea Le, OD, MBA - Manager, Global Medical Affairs

Johnson & Johnson Vision Care Inc.

Phone: 904 4431866

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60