Trial Outcomes & Findings for Comparison of Two Marketed Lenses in a Controlled Environment (NCT NCT02212301)

Results Overview

The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

8 hour post insertion

Results posted on

2016-10-28

Participant Flow

A total of 45 subjects were enrolled into this study. Of the enrolled subjects 43 were dispensed and 2 subjects did not meet the eligibility criteria. Of the 43 dispensed subjects, 1 subject was discontinued 42 subjects completed the study.

Participant milestones

Participant milestones
Measure	Senofilcon A/ Lotrafilcon B Subjects that received the senofilcon A contact lens in the first period and then received the lotrafilcon B contact lens in the second period.	Lotrafilcon B / Senofilcon A Subjects that received the lotrafilcon B contact lens in the first period and then received the senofilcon A contact lens in the second period.
Period 1 STARTED	21	22
Period 1 COMPLETED	21	21
Period 1 NOT COMPLETED	0	1
Period 2 STARTED	21	21
Period 2 COMPLETED	21	21
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Senofilcon A/ Lotrafilcon B Subjects that received the senofilcon A contact lens in the first period and then received the lotrafilcon B contact lens in the second period.	Lotrafilcon B / Senofilcon A Subjects that received the lotrafilcon B contact lens in the first period and then received the senofilcon A contact lens in the second period.
Period 1 Lost to Follow-up	0	1

Baseline Characteristics

Comparison of Two Marketed Lenses in a Controlled Environment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=43 Participants All subjects that were dispensed at least one lens throughout the duration of the study.
Age, Continuous	35.1 Years STANDARD_DEVIATION 7.78 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United Kingdom	43 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 hour post insertion

Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subjects was excluded from the analysis population due to a major protocol deviation.

The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.

Outcome measures

Outcome measures
Measure	Senofilcon A n=41 Participants Subjects that received the senofilcon A contact lens in either the first or second period of the study.	Lotrafilcon B n=41 Participants Subjects that received the lotrafilcon B in either the first or second period of the study.
Tear Film Kinetics	5.590 Seconds Standard Deviation 4.2705	6.941 Seconds Standard Deviation 6.1257

PRIMARY outcome

Timeframe: 8 hours post insertion

Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens at both near (40cm) and far distance (4m).

The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17" LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3" LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units.

Outcome measures

Outcome measures
Measure	Senofilcon A n=41 Participants Subjects that received the senofilcon A contact lens in either the first or second period of the study.	Lotrafilcon B n=41 Participants Subjects that received the lotrafilcon B in either the first or second period of the study.
Time Controlled Visual Acuity Distance	-0.06 LogMAR Standard Deviation 0.092	-0.07 LogMAR Standard Deviation 0.075
Time Controlled Visual Acuity Intermediate	0.07 LogMAR Standard Deviation 0.077	0.06 LogMAR Standard Deviation 0.074

Adverse Events

Senofilcon A

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Lotrafilcon B

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Senofilcon A n=43 participants at risk Subjects that received the senofilcon A contact lens in either the first or second period of the study.	Lotrafilcon B n=43 participants at risk Subjects that received the lotrafilcon B contact lens in either the first or second period of the study.
General disorders Cold	7.0% 3/43 • Number of events 3 • Throughout the duration of the study. Approximately 1 month per subject.	9.3% 4/43 • Number of events 5 • Throughout the duration of the study. Approximately 1 month per subject.

Additional Information

Tawnya Wilson OD

Johnson & Johnson Vision Care Inc.

Phone: 904-443-3500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60