Trial Outcomes & Findings for Clinical Evaluation of ACUVUE® OASYS® 1-Day and ACUVUE® OASYS® (NCT NCT02696317)

Results Overview

Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 3 hours of wear in a normal environment after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

Day 10 ± 3 days, each product

Results posted on

2018-07-02

Participant Flow

Subjects were recruited from one study center located in the United Kingdom.

Of the 84 enrolled, 1 subject was exited as a screen failure prior to randomization. One subject was discontinued after randomization but prior to study lenses parameter optimization. This reporting group includes all subjects exposed to habitual or study lenses (82).

Participant milestones

Participant milestones
Measure	Habitual, AO1D, AO Habitual contact lenses worn first (to understand the baseline performance in this population), followed by senofilcon A contact lenses with HydraLuxe™ in Period 1 and senofilcon A contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.	Habitual, AO, AO1D Habitual contact lenses worn first (to understand the baseline performance in this population), followed by senofilcon A contact lenses in Period 1, then senofilcon A contact lenses with HydraLuxe™ in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
Habitual, 10 Days of Wear STARTED	42	40
Habitual, 10 Days of Wear COMPLETED	40	36
Habitual, 10 Days of Wear NOT COMPLETED	2	4
Period 1, 10 Days of Wear STARTED	40	36
Period 1, 10 Days of Wear COMPLETED	40	36
Period 1, 10 Days of Wear NOT COMPLETED	0	0
Period 2, 10 Days of Wear STARTED	40	36
Period 2, 10 Days of Wear COMPLETED	39	36
Period 2, 10 Days of Wear NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Habitual, AO1D, AO Habitual contact lenses worn first (to understand the baseline performance in this population), followed by senofilcon A contact lenses with HydraLuxe™ in Period 1 and senofilcon A contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.	Habitual, AO, AO1D Habitual contact lenses worn first (to understand the baseline performance in this population), followed by senofilcon A contact lenses in Period 1, then senofilcon A contact lenses with HydraLuxe™ in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
Habitual, 10 Days of Wear Withdrawal by Subject	2	4
Period 2, 10 Days of Wear Withdrawal by Subject	1	0

Baseline Characteristics

Clinical Evaluation of ACUVUE® OASYS® 1-Day and ACUVUE® OASYS®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=82 Participants Habitual contact lenses worn first, followed by senofilcon A contact lenses with HydraLuxe™ and senofilcon A contact lenses in Periods 1 and 2, as randomized. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
Age, Continuous	35.3 years STANDARD_DEVIATION 11.93 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 10 ± 3 days, each product

Population: Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.

Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 3 hours of wear in a normal environment after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.

Outcome measures

Outcome measures
Measure	ACUVUE OASYS 1-DAY n=152 Eyes Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality	ACUVUE OASYS n=150 Eyes Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH) 25-35% Relative Humidity	11.97 10^-7g/cm^2/s Standard Deviation 6.447	10.66 10^-7g/cm^2/s Standard Deviation 5.700
Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH) 35-45% Relative Humidity	8.51 10^-7g/cm^2/s Standard Deviation 5.562	7.94 10^-7g/cm^2/s Standard Deviation 5.289

SECONDARY outcome

Timeframe: Day 10 ± 3 days, each product

Population: Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.

Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 6 hours of lens wear, including 3 hours of wear in a 20% reduced humidity environment (20% RH), after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.

Outcome measures

Outcome measures
Measure	ACUVUE OASYS 1-DAY n=152 Eyes Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality	ACUVUE OASYS n=150 Eyes Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH) 25-35% Relative Humidity	11.51 10^-7g/cm^2/s Standard Deviation 5.773	11.72 10^-7g/cm^2/s Standard Deviation 5.830
Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH) 35-45% Relative Humidity	8.78 10^-7g/cm^2/s Standard Deviation 5.732	8.68 10^-7g/cm^2/s Standard Deviation 5.352

SECONDARY outcome

Timeframe: Day 10 ± 3 days, each product

Population: Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.

MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed in a normal environment following 3 hours of wear. Higher values indicate less dry and more eye comfort.

Outcome measures

Outcome measures
Measure	ACUVUE OASYS 1-DAY n=152 Eyes Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality	ACUVUE OASYS n=150 Eyes Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)	84.64 percentage of contact lens surface area Standard Deviation 27.835	85.37 percentage of contact lens surface area Standard Deviation 25.634

SECONDARY outcome

Timeframe: Day 10 ± 3 days, each product

Population: Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.

MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed following 6 hours of wear including 3 hours in a reduced humidity environment (20% RH).. Higher values indicate less dry and more eye comfort.

Outcome measures

Outcome measures
Measure	ACUVUE OASYS 1-DAY n=152 Eyes Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality	ACUVUE OASYS n=150 Eyes Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)	94.14 percentage of contact lens surface area Standard Deviation 14.399	91.61 percentage of contact lens surface area Standard Deviation 20.004

Adverse Events

Pre-treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Habitual Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ACUVUE OASYS 1-DAY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ACUVUE OASYS

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

Sr. Brand Lead, Global Medical Affairs, Vision Care

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER