Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03341923
• Collaborator: (none)
• Enrollment: 151
• Locations: 4
• Arms: 2
• Actual Duration (Months): 5.5
• Patients Per Site: 37.8
• Patients Per Site Per Month: 6.9

Study Details

Study Description

Brief Summary

The purpose of this clinical study is to evaluate DAILIES TOTAL1® Multifocal (DT1MF) contact lenses compared to 1-DAY ACUVUE® Moist® Multifocal (AMMF) contact lenses for investigator-graded lens centration in a Japanese population.

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

Detailed Description

Subjects will be randomly assigned to one of two sequences of investigational product wear ((DT1MF→AMMF, AMMF→DT1MF). Each product will be worn in both eyes for at least 11 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population
• Actual Study Start Date: Dec 20, 2017
• Actual Primary Completion Date: Jun 5, 2018
• Actual Study Completion Date: Jun 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: DT1MF, then AMMF Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.	Device: Delefilcon A multifocal contact lenses; Silicone hydrogel multifocal contact lenses for daily disposable wear; Other Names: DAILIES TOTAL 1® Multifocal ; Device: Etafilcon A multifocal contact lenses; Hydrogel multifocal contact lenses for daily disposable wear; Other Names: 1-DAY ACUVUE® Moist® Multifocal
Other: AMMF, then DT1MF Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.	Device: Delefilcon A multifocal contact lenses; Silicone hydrogel multifocal contact lenses for daily disposable wear; Other Names: DAILIES TOTAL 1® Multifocal ; Device: Etafilcon A multifocal contact lenses; Hydrogel multifocal contact lenses for daily disposable wear; Other Names: 1-DAY ACUVUE® Moist® Multifocal

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With Investigator-graded Lens Centration of "Optimal" [Day 14, each product]

   Lens centration was assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure). One target eye was randomly selected for analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Sign informed consent

• Habitually wear multifocal soft/ silicone hydrogel contact lenses

• Require a near spectacle ADD of +0.50 diopters (D) to +2.50D (inclusive)

• Correctable to 20/30 Snellen or 0.2 logarithm minimum angle of resolution (logMAR) or better in each eye at distance

• Willing to wear contact lenses and attend all study visits

Exclusion Criteria:

• Currently wearing DAILIES TOTAL 1® Multifocal or 1-DAY ACUVUE® Moist® Multifocal contact lenses

• Any eye condition that would make contact lens wear unadvisable

• Any use of medication that would make contact lens wear unadvisable

• Prior refractive surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Koto-Ku	Tokyo	Japan	136-0071
2	Alcon Investigative Site	Nakano-ku	Tokyo	Japan	164-0001
3	Alcon Investigative Site	Shinagawa-Ku	Tokyo	Japan	141-0021
4	Alcon Investigative Site	Taitō	Tokyo	Japan	110-0005

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jan 22, 2018
• Statistical Analysis Plan - Mar 16, 2015

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT03341923
• Other Study ID Numbers: CLJ369-P001
• First Posted: Nov 14, 2017
• Last Update Posted: Apr 16, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Alcon Research: contact lenses; lens centration; multifocal
• Additional relevant MeSH terms: Presbyopia; Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 4 study sites located in Japan.
Pre-assignment Detail	Of the 151 enrolled, 17 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (134).

Arm/Group Title	DT1MF, Then AMMF	AMMF, Then DT1MF
Arm/Group Description	Delefilcon A multifocal contact lenses, followed by etafilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.	Etafilcon A multifocal contact lenses, followed by delefilcon A multifocal contact lenses. Each product worn in both eyes for 14 +/- 3 days.
Period Title: Period 1, First 14 Days of Wear
STARTED	67	67
COMPLETED	67	67
NOT COMPLETED	0	0
Period Title: Period 1, First 14 Days of Wear
STARTED	67	66
COMPLETED	67	65
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Delefilcon A multifocal contact lenses and etafilcon A multifocal contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
Overall Participants	134
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.1 (5.1)
Sex: Female, Male (Count of Participants)
Female	103 76.9%
Male	31 23.1%
Race/Ethnicity, Customized (Count of Participants)
Japanese	134 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Investigator-graded Lens Centration of "Optimal"
Description	Lens centration was assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure). One target eye was randomly selected for analysis.
Time Frame	Day 14, each product

Outcome Measure Data

Analysis Population Description

Full Analysis Set with data available

Arm/Group Title	DT1MF	AMMF
Arm/Group Description	Delefilcon A multifocal contact lenses worn binocularly during Period 1 or Period 2 for 14 +/- 3 days, as randomized.	Etafilcon A multifocal contact lenses worn binocularly during Period 1 or Period 2 for 14 +/- 3 days, as randomized.
Measure Participants	132	133
Number [percentage of subjects]	97.0	91.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DT1MF, AMMF
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Difference (DT1MF-AMMF) of percentage of subjects rated as "Optimal" was provided with two-sided 95% confidence interval (CI). If lower limit of CI was above -10% as non-inferiority criteria, non-inferiority was to be demonstrated.
Statistical Test of Hypothesis	p-Value	0.0455
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	6.1
	Confidence Interval	(2-Sided) 95%; 0.2 to 11.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DT1MF, AMMF
	Comments
	Type of Statistical Test	Superiority
	Comments	After demonstrating noninferiority, if lower limit of CI was above 0% as superiority criteria, superiority was to be demonstrated.
Statistical Test of Hypothesis	p-Value	0.0455
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	6.1
	Confidence Interval	(2-Sided) 95%; 0.2 to 11.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Baseline through study completion, an average of 28 days
Adverse Event Reporting Description	Safety was assessed at each visit. This analysis population includes all data of subjects who used the investigational medical devices. Lenses used at Visit 1 (baseline) for the selection of parameters are not regarded as investigational medical devices (Safety Analysis Set, based on treatment-specific exposure). "At Risk" population for ocular Adverse Events is included with unit of "eyes."
Arm/Group Title	DT1MF Ocular		DT1MF Systemic		AMMF Ocular		AMMF Systemic
Arm/Group Description	Eyes exposed to delefilcon A multifocal contact lenses		Subjects exposed to delefilcon A multifocal contact lenses		Eyes exposed to etafilcon A multifocal contact lenses		Subjects exposed to etafilcon A multifocal contact lenses
All Cause Mortality
	DT1MF Ocular		DT1MF Systemic		AMMF Ocular		AMMF Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/266 (0%)		0/133 (0%)		0/268 (0%)		0/134 (0%)
Serious Adverse Events
	DT1MF Ocular		DT1MF Systemic		AMMF Ocular		AMMF Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/266 (0%)		0/133 (0%)		0/268 (0%)		0/134 (0%)
Other (Not Including Serious) Adverse Events
	DT1MF Ocular		DT1MF Systemic		AMMF Ocular		AMMF Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	88/266 (33.1%)		0/133 (0%)		82/268 (30.6%)		0/134 (0%)
Eye disorders
Visual impairment	82/266 (30.8%)		0/133 (0%)		70/268 (26.1%)		0/134 (0%)
Asthenopia	24/266 (9%)		0/133 (0%)		14/268 (5.2%)		0/134 (0%)
Dry eye	6/266 (2.3%)		0/133 (0%)		24/268 (9%)		0/134 (0%)
Ocular discomfort	6/266 (2.3%)		0/133 (0%)		20/268 (7.5%)		0/134 (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.