Trial Outcomes & Findings for Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens (NCT NCT01484028)

Results Overview

Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a\*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

275 participants

Primary outcome timeframe

Dispensing

Results posted on

2018-06-19

Participant Flow

Of those 275 enrolled subjects, 267 subjects were randomized and received the study article in the study. Two subjects were discontinued between the first and second periods.

Participant milestones

Participant milestones
Measure	1DM/EADE etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for dark eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.	1DM/EALE etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for light eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.	EADE/1DM etafilcon A for dark eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.	EALE/1DM etafilcon A for light eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
Period 1 STARTED	66	70	64	67
Period 1 COMPLETED	66	67	64	66
Period 1 NOT COMPLETED	0	3	0	1
Period 2 STARTED	66	67	64	66
Period 2 COMPLETED	66	67	64	66
Period 2 NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	1DM/EALE etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for light eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.	EALE/1DM etafilcon A for light eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
Period 1 Lost to Follow-up	1	0
Period 1 Non-Compliance to Protocol	1	1
Period 1 Lens Discomfort	1	0

Baseline Characteristics

Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=267 Participants All randomized subjects who worn at least one pair of study lenses.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	267 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	24.94 years STANDARD_DEVIATION 4.654 • n=5 Participants
Sex: Female, Male Female	267 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Dispensing

Population: Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.

Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a\*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.

Outcome measures

Outcome measures
Measure	EADE/EALE n=528 eyes etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.	1-DM n=530 eyes A marketed daily disposable contact lens to correct myopia.
Monocular Visual Acuity	-0.044 LogMAR score Standard Deviation 0.0618	-0.060 LogMAR score Standard Deviation 0.0589

PRIMARY outcome

Timeframe: Dispensing

Population: Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.

The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).

Outcome measures

Outcome measures
Measure	EADE/EALE n=528 eyes etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.	1-DM n=530 eyes A marketed daily disposable contact lens to correct myopia.
Lens Fit Acceptance	100 % of Eyes Interval 98.3 to 100.0	100 % of Eyes Interval 98.3 to 100.0

PRIMARY outcome

Timeframe: After 7-9 days of lens wear

Population: Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.

Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade \>= 3 were reported.

Outcome measures

Outcome measures
Measure	EADE/EALE n=528 eyes etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.	1-DM n=526 eyes A marketed daily disposable contact lens to correct myopia.
Corneal Staining of Grade 3 or 4	0 % of Eyes Interval 0.0 to 1.7	0 % of Eyes Interval 0.0 to 1.7

Adverse Events

Etafilcon A With PVP for Dark/Light Eyes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon A Control Lenses

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

Dr. Michael Mayers, O.D., FAAO, Senior Research Optometrist

Vistakon, Johnson and Johnson Vision Care

Phone: 1 904 443 3252

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place