Trial Outcomes & Findings for Comparative Clinical Evaluation of Soft Toric Lens Designs (NCT NCT01552876)

Results Overview

At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

At 1-min after lens insertion during Phase I

Results posted on

2018-06-19

Participant Flow

Subjects are considered to be enrolled and not randomized at baseline. There were 42 subjects enrolled and 2 that were not randomized for a study baseline population of 40.

Participant milestones

Participant milestones
Measure	Etafilcon A/ Nelfilcon A/Filcon II 3 etafilcon A worn first, nelfilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5).	Nelfilcon A/ Etafilcon A/ Filcon II 3 nelfilcon A worn first, etafilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5).
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Clinical Evaluation of Soft Toric Lens Designs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=42 Participants All subjects who were enrolled at baseline.
Age, Continuous	51.45 years STANDARD_DEVIATION 12.707 • n=93 Participants
Sex: Female, Male Female	32 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Region of Enrollment United Kingdom	42 participants n=93 Participants

PRIMARY outcome

Timeframe: At 1-min after lens insertion during Phase I

Population: Subjects included in the analysis were those who were enrolled, randomized, and completed the study.

At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.

Outcome measures

Outcome measures
Measure	Etafilcon A n=80 eyes Those subjects who wore etafilcon A.	Nelfilcon A n=80 eyes Those subjects who wore nelfilcon A.	Filcon II 3 All subjects wore the Filcon II 3 lens after the wearing of the etafilcon and nelfilcon lenses.
Phase I: Absolute Lens Rotation	6.73 Degrees Interval 5.29 to 8.56	11.38 Degrees Interval 8.95 to 14.48	—

PRIMARY outcome

Timeframe: 3 min after lens insertion during Phase I

Population: Analysis was on those subjects who were enrolled, randomized, and completed the study.

Lens orientation position as assessed on a scale of 0-180 on both eyes.

Outcome measures

Outcome measures
Measure	Etafilcon A n=80 eyes Those subjects who wore etafilcon A.	Nelfilcon A n=80 eyes Those subjects who wore nelfilcon A.	Filcon II 3 All subjects wore the Filcon II 3 lens after the wearing of the etafilcon and nelfilcon lenses.
Phase I: Absolute Lens Rotation	6.26 Degrees Interval 4.92 to 7.97	11.06 Degrees Interval 8.7 to 14.07	—

SECONDARY outcome

Timeframe: 5 minutes after lens insertion during Phase I

Population: Subjects analyzed were those who were enrolled, randomized, and completed the study.

With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling.

Outcome measures

Outcome measures
Measure	Etafilcon A n=40 Participants Those subjects who wore etafilcon A.	Nelfilcon A n=40 Participants Those subjects who wore nelfilcon A.	Filcon II 3 All subjects wore the Filcon II 3 lens after the wearing of the etafilcon and nelfilcon lenses.
Phase I: Time to Lens Settling	1.60 minutes Interval 1.25 to 2.04	1.82 minutes Interval 1.43 to 2.32	—

SECONDARY outcome

Timeframe: Baseline to 5 minutes during Phase I

Population: Subjects analyzed are those who were enrolled, randomized, and completed the study.

Number of blinks for the right eye was counted until lens settling using headcam video.

Outcome measures

Outcome measures
Measure	Etafilcon A n=40 Participants Those subjects who wore etafilcon A.	Nelfilcon A n=40 Participants Those subjects who wore nelfilcon A.	Filcon II 3 All subjects wore the Filcon II 3 lens after the wearing of the etafilcon and nelfilcon lenses.
Phase I: Number of Blinks Until Settled	57.29 Blinks Standard Error 6.65	74.73 Blinks Standard Error 4.56	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-minute during Phase II

Population: Analysis was on those subjects who were enrolled, randomized, and completed the study.

Absolute rotation of the lens (degrees) at 1-minute post-fit on both eyes. Filcon II 3 lens was only used for comparison in phase II of the study per study protocol.

Outcome measures

Outcome measures
Measure	Etafilcon A n=80 eyes Those subjects who wore etafilcon A.	Nelfilcon A n=80 eyes Those subjects who wore nelfilcon A.	Filcon II 3 n=80 eyes All subjects wore the Filcon II 3 lens after the wearing of the etafilcon and nelfilcon lenses.
Phase II: Absolute Rotation	9.99 Degrees Standard Deviation 14.194	17.54 Degrees Standard Deviation 17.431	16.59 Degrees Standard Deviation 30.820

Adverse Events

Etafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nelfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Filcon II 3

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

Katherine Osborn OD, MS FAAO

Johnson & Johnson Vision Care

Phone: 1 904 443-1032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60