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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02696317
• Collaborator: (none)
• Enrollment: 84
• Arms: 2
• Actual Duration (Months): 2.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the performance of two commercially-available silicone hydrogel contact lenses in normal and low humidity environments after at least 7 days of wear.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: Senofilcon A contact lenses with HydraLuxe™; Device: Senofilcon A contact lenses	N/A

Detailed Description

After randomization to lens order, subjects attended study visits that included a 3 hour exposure to reduced humidity environment (20% relative humidity) and subsequent tear film assessments for each study lens.

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: Clinical Evaluation of ACUVUE® OASYS® 1-Day Daily Disposable Silicone Hydrogel Contact Lenses
• Actual Study Start Date: Mar 18, 2016
• Actual Primary Completion Date: Jun 6, 2016
• Actual Study Completion Date: Jun 6, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: AO1D, then AO Senofilcon A contact lenses with HydraLuxe™, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality.	Device: Senofilcon A contact lenses with HydraLuxe™; Contact lenses worn during Period 1 or 2, as randomized; Other Names: ACUVUE® OASYS® 1-Day Contact Lenses with HydraLuxe™ (AO1D) ; Device: Senofilcon A contact lenses; Contact lenses worn during Period 1 or 2, as randomized; Other Names: ACUVUE® OASYS® (AO)
Other: AO, then AO1D Senofilcon A contact lenses, followed by senofilcon A contact lenses with HydraLuxe™. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.	Device: Senofilcon A contact lenses with HydraLuxe™; Contact lenses worn during Period 1 or 2, as randomized; Other Names: ACUVUE® OASYS® 1-Day Contact Lenses with HydraLuxe™ (AO1D) ; Device: Senofilcon A contact lenses; Contact lenses worn during Period 1 or 2, as randomized; Other Names: ACUVUE® OASYS® (AO)

Outcome Measures

Primary Outcome Measures

1. Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH) [Day 10 ± 3 days, each product]

   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.

Secondary Outcome Measures

1. Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH) [Day 10 ± 3 days, each product]

   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.

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

   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.

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

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must sign an informed consent form;

• Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months;

• Prescription within power range of both study contact lenses, as stated in the protocol;

• Cylinder equal or lower than -0.75 diopter (D) in both eyes;

• Willing to wear lenses every day or at least a minimum of 5 days per week, 6 hours per day;

• Willing to discontinue artificial tears and rewetting drops on the days of study visits;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;

• Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;

• Monocular (only 1 eye with functional vision) or fit with only 1 lens;

• History of herpetic keratitis, ocular surgery, or irregular cornea;

• Pregnant or lactating;

• Current AO1D or AO lens wearer;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Senior Clinical Manager, GCRA Operations, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02696317
• Other Study ID Numbers: CLE198-P001
• First Posted: Mar 2, 2016
• Last Update Posted: Jul 2, 2018
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from one study center located in the United Kingdom.
Pre-assignment Detail	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
Period Title: Habitual, 10 Days of Wear
STARTED	40	36
COMPLETED	40	36
NOT COMPLETED	0	0
Period Title: Habitual, 10 Days of Wear
STARTED	40	36
COMPLETED	39	36
NOT COMPLETED	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 Participants	82
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.3 (11.93)
Sex: Female, Male (Count of 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
Measure Participants	76	75
Measure Eyes	152	150
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
Measure Participants	76	75
Measure Eyes	152	150
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
Measure Participants	76	75
Measure Eyes	152	150
Mean (Standard Deviation) [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
Measure Participants	76	75
Measure Eyes	152	150
Mean (Standard Deviation) [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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/82 (0%)		0/76 (0%)		0/76 (0%)
Serious Adverse Events
	Pre-treatment		Habitual Lenses		ACUVUE OASYS 1-DAY		ACUVUE OASYS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/82 (0%)		0/76 (0%)		0/76 (0%)
Other (Not Including Serious) Adverse Events
	Pre-treatment		Habitual Lenses		ACUVUE OASYS 1-DAY		ACUVUE OASYS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/82 (0%)		0/76 (0%)		0/76 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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