ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®

• Sponsor: Alcon, a Novartis Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02750813
• Collaborator: (none)
• Enrollment: 252
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.7
• Patients Per Site Per Month: 68.5

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 252 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®: Clinical Comparison in a Symptomatic Population
• Actual Study Start Date: Apr 27, 2016
• Actual Primary Completion Date: Aug 17, 2016
• Actual Study Completion Date: Aug 17, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: DT1, then AO1D Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.	Device: Delefilcon A contact lenses; Other Names: DAILIES TOTAL1® (DT1) ; Device: Senofilcon A contact lenses; Other Names: ACUVUE® OASYS 1-Day with HydraLuxe™ (AO1D)
Other: AO1D, then DT1 Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.	Device: Delefilcon A contact lenses; Other Names: DAILIES TOTAL1® (DT1) ; Device: Senofilcon A contact lenses; Other Names: ACUVUE® OASYS 1-Day with HydraLuxe™ (AO1D)

Outcome Measures

Primary Outcome Measures

1. Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14 [Day 14, each product]

   Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.

Secondary Outcome Measures

1. Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14 [Day 14, each product]

   The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Must sign informed consent form;

• Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;

• Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;

• Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;

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

• Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;

• Can be successfully fitted with both study lenses at Visit 1;

• Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all 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;

• Fitted with monovision;

• Prior refractive surgery;

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

• Pregnant or lactating;

• Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;

• Participation in any clinical study within 30 days of Visit 1;

• Current DT1 or AO1D lens wearer;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon, a Novartis Company

Investigators

• Study Director: Sr. Clinical Manager, Global Medical Affairs, GCRA, Alcon, A Novartis Division

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon, a Novartis Company
• ClinicalTrials.gov Identifier: NCT02750813
• Other Study ID Numbers: CLV771-P001
• First Posted: Apr 26, 2016
• Last Update Posted: Jul 2, 2018
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 12 study centers located in the United States.
Pre-assignment Detail	Of the 252 enrolled, 5 subjects were exited prior to randomization and 1 randomized subject was exited prior to treatment. This reporting group includes all randomized subjects who were exposed to a study product (test or control) (246).

Arm/Group Title	DT1, Then AO1D	AO1D, Then DT1
Arm/Group Description	Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.	Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.
Period Title: Period 1, First 14 Days of Wear
STARTED	125	121
COMPLETED	124	120
NOT COMPLETED	1	1
Period Title: Period 1, First 14 Days of Wear
STARTED	124	120
COMPLETED	124	120
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Delefilcon A and senofilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Overall Participants	246
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.7 (8.44)
Sex: Female, Male (Count of Participants)
Female	183 74.4%
Male	63 25.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14
Description	Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.
Time Frame	Day 14, 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	DAILIES TOTAL1	AO1D
Arm/Group Description	Delefilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality	Senofilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality
Measure Participants	244	244
Measure Eyes	488	488
Number [percentage of lenses]	100.0	99.4

2. Secondary Outcome

Title	Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14
Description	The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.
Time Frame	Day 14, each product

Outcome Measure Data

Analysis Population Description

Full Analysis Set. Number Analyzed is the number of eyes with non-missing responses, including only subjects from one site.

Arm/Group Title	DAILIES TOTAL1	AO1D
Arm/Group Description	Delefilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality	Senofilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality
Measure Participants	17	17
Measure Eyes	17	17
Mean (Standard Deviation) [unitless]	0.0468 (0.00557)	0.0675 (0.00599)

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 35 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	Pretreatment		DAILIES TOTAL1 (DT1)		ACUVUE OASYS 1-DAY (AO1D)
Arm/Group Description	All subjects who consented to participate in the study prior to initiation of study treatment		All subjects exposed to DT1 contact lenses, except for lenses used for parameter optimization and fitting		All subjects exposed to AO1D contact lenses, except for lenses used for parameter optimization and fitting
All Cause Mortality
	Pretreatment		DAILIES TOTAL1 (DT1)		ACUVUE OASYS 1-DAY (AO1D)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/252 (0%)		0/246 (0%)		0/246 (0%)
Serious Adverse Events
	Pretreatment		DAILIES TOTAL1 (DT1)		ACUVUE OASYS 1-DAY (AO1D)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/252 (0%)		0/246 (0%)		0/246 (0%)
Other (Not Including Serious) Adverse Events
	Pretreatment		DAILIES TOTAL1 (DT1)		ACUVUE OASYS 1-DAY (AO1D)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/252 (0%)		0/246 (0%)		0/246 (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.