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

• ClinicalTrials.gov Identifier: NCT02696317
• Recruitment Status: Completed
• First Posted: March 2, 2016
• Results First Posted: June 26, 2017
• Last Update Posted: July 2, 2018
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Investigator); Primary Purpose: Other
• Condition: Refractive Error
• Interventions: Device: Senofilcon A contact lenses with HydraLuxe™; Device: Senofilcon A contact lenses
• Enrollment: 84

Participant Flow

Recruitment Details	Subjects were recruited from one study center located in the United Kingdom.
Pre-assignment Details	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).

Arm/Group Title	Habitual, AO1D, AO	Habitual, AO, AO1D
Arm/Group Description	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 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.
Period Title: Habitual, 10 Days of Wear
Started	42	40
Completed	40	36
Not Completed	2	4
Reason Not Completed
Withdrawal by Subject	2	4
Period Title: Period 1, 10 Days of Wear
Started	40	36
Completed	40	36
Not Completed	0	0
Period Title: Period 2, 10 Days of Wear
Started	40	36
Completed	39	36
Not Completed	1	0
Reason Not Completed
Withdrawal by Subject	1	0

Baseline Characteristics

Arm/Group Title		Overall
Arm/Group Description		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.
Overall Number of Baseline Participants		82
Baseline Analysis Population Description		This analysis population includes all randomized subjects who were exposed to any study lenses used for parameter optimization, habitual lenses, or study lenses dispensed for 10-day wear (Full Analysis Set).
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	82 participants
		35.3 (11.93)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	82 participants
	Female	55 67.1%
	Male	27 32.9%

Outcome Measures

1. Primary Outcome

Title	Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
Description	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.
Time Frame	Day 10 ± 3 days, each product

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACUVUE OASYS 1-DAY	ACUVUE OASYS
Arm/Group Description:	Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality	Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
Overall Number of Participants Analyzed	76	75
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes	152	150
Mean (Standard Deviation); Unit of Measure: 10^-7g/cm^2/s
25-35% Relative Humidity	11.97 (6.447)	10.66 (5.700)
35-45% Relative Humidity	8.51 (5.562)	7.94 (5.289)

2. Secondary Outcome

Title	Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)
Description	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.
Time Frame	Day 10 ± 3 days, each product

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACUVUE OASYS 1-DAY	ACUVUE OASYS
Arm/Group Description:	Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality	Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
Overall Number of Participants Analyzed	76	75
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes	152	150
Mean (Standard Deviation); Unit of Measure: 10^-7g/cm^2/s
25-35% Relative Humidity	11.51 (5.773)	11.72 (5.830)
35-45% Relative Humidity	8.78 (5.732)	8.68 (5.352)

3. Secondary Outcome

Title	Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)
Description	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.
Time Frame	Day 10 ± 3 days, each product

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACUVUE OASYS 1-DAY	ACUVUE OASYS
Arm/Group Description:	Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality	Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
Overall Number of Participants Analyzed	76	75
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes	152	150
Mean (Standard Deviation); Unit of Measure: percentage of contact lens surface area
	84.64 (27.835)	85.37 (25.634)

4. Secondary Outcome

Title	Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)
Description	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.
Time Frame	Day 10 ± 3 days, each product

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ACUVUE OASYS 1-DAY	ACUVUE OASYS
Arm/Group Description:	Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality	Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
Overall Number of Participants Analyzed	76	75
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes	152	150
Mean (Standard Deviation); Unit of Measure: percentage of contact lens surface area
	94.14 (14.399)	91.61 (20.004)

Adverse Events

Time Frame	Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 39 days). AEs are reported as pre-treatment and treatment-emergent.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.
Arm/Group Title	Pre-treatment	Habitual Lenses	ACUVUE OASYS 1-DAY	ACUVUE OASYS
Arm/Group Description	All subjects who consented to participate in the study prior to initiation of study treatment	All subjects exposed to habitual contact lenses during Period 1	All subjects exposed to ACUVUE OASYS 1-DAY contact lenses	All subjects exposed to ACUVUE OASYS contact lenses
All-Cause Mortality
	Pre-treatment	Habitual Lenses	ACUVUE OASYS 1-DAY	ACUVUE OASYS
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/84 (0.00%)	0/82 (0.00%)	0/76 (0.00%)	0/76 (0.00%)
Serious Adverse Events
	Pre-treatment	Habitual Lenses	ACUVUE OASYS 1-DAY	ACUVUE OASYS
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/84 (0.00%)	0/82 (0.00%)	0/76 (0.00%)	0/76 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Pre-treatment	Habitual Lenses	ACUVUE OASYS 1-DAY	ACUVUE OASYS
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/84 (0.00%)	0/82 (0.00%)	0/76 (0.00%)	0/76 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.

Results Point of Contact

• Name/Title: Sr. Brand Lead, Global Medical Affairs, Vision Care
• Organization: Alcon, A Novartis Division
• Phone: 1-888-451-3937
• EMail: alcon.medinfo@alcon.com

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02696317
• Other Study ID Numbers: CLE198-P001
• First Submitted: February 24, 2016
• First Posted: March 2, 2016
• Results First Submitted: June 5, 2017
• Results First Posted: June 26, 2017
• Last Update Posted: July 2, 2018