Performance Assessment of a Modified Daily Disposable Contact Lens

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03762668
• Collaborator: (none)
• Enrollment: 62
• Locations: 5
• Arms: 2
• Actual Duration (Months): 1.1
• Patients Per Site: 12.4
• Patients Per Site Per Month: 10.8

Study Details

Study Description

Brief Summary

The purpose of this study is to compare visual acuity between two daily disposable contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors; Myopia; Hyperopia	Device: Modified delefilcon A contact lenses; Device: Delefilcon A contact lenses	N/A

Detailed Description

The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Performance Assessment of a Modified Daily Disposable Contact Lens
• Actual Study Start Date: Dec 3, 2018
• Actual Primary Completion Date: Jan 7, 2019
• Actual Study Completion Date: Jan 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: MDACL, then DACL Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.	Device: Modified delefilcon A contact lenses; Spherical soft daily disposable contact lens; Other Names: MDACL ; Device: Delefilcon A contact lenses; Spherical soft daily disposable contact lens; Other Names: DACL
Other: DACL, then MDACL DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.	Device: Modified delefilcon A contact lenses; Spherical soft daily disposable contact lens; Other Names: MDACL ; Device: Delefilcon A contact lenses; Spherical soft daily disposable contact lens; Other Names: DACL

Outcome Measures

Primary Outcome Measures

1. High Contrast Distance Visual Acuity (logMAR) [Day 1 Dispense, Day 7 Follow-Up]

   Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Able to understand and sign an approved Informed Consent form;

• Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any eye condition that contraindicates contact lens wear, as determined by the Investigator;

• Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;

• Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)

• Monocular (only one eye with functional vision);

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Maitland	Florida	United States	32751
2	Alcon Investigative Site	Orlando	Florida	United States	32803
3	Alcon Investigative Site	West Palm Beach	Florida	United States	33405
4	Alcon Investigative Site	Ann Arbor	Michigan	United States	48105
5	Alcon Investigative Site	Memphis	Tennessee	United States	38111

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Sr. CDMA Project Lead, Vision Care, Alcon Research

Study Documents (Full-Text)

• Statistical Analysis Plan - Nov 30, 2018
• Study Protocol - Nov 7, 2018

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT03762668
• Other Study ID Numbers: CLP691-C002
• First Posted: Dec 4, 2018
• Last Update Posted: Jan 13, 2020
• Last Verified: Jan 1, 2020

• 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.: No
• Keywords provided by Alcon Research: Contact lens; Vision correction; Visual acuity
• Additional relevant MeSH terms: Refractive Errors; Hyperopia

Study Results

Participant Flow

Recruitment Details	This study was conducted at 5 investigative sites located in the United States.
Pre-assignment Detail	Of the 62 subjects enrolled, 2 were exited as screen failures prior to randomization. This reporting group includes all randomized and exposed subjects (60).

Arm/Group Title	MDACL, Then DACL	DACL, Then MDACL
Arm/Group Description	Modified delefilcon A contact lenses (MADCL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.	DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
Period Title: Period 1, First Week of Wear
STARTED	30	30
COMPLETED	30	29
NOT COMPLETED	0	1
Period Title: Period 1, First Week of Wear
STARTED	30	29
COMPLETED	30	29
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	MDACL, Then DACL	DACL, Then MDACL	Total
Arm/Group Description	MDACL worn first, followed by DACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.	DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.7 (9.3)	30.7 (8.6)	31.7 (9.0)
Sex: Female, Male (Count of Participants)
Female	23 76.7%	24 80%	47 78.3%
Male	7 23.3%	6 20%	13 21.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 6.7%	4 13.3%	6 10%
Not Hispanic or Latino	28 93.3%	26 86.7%	54 90%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	2 6.7%	2 3.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 3.3%	2 6.7%	3 5%
White	29 96.7%	26 86.7%	55 91.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	High Contrast Distance Visual Acuity (logMAR)
Description	Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.
Time Frame	Day 1 Dispense, Day 7 Follow-Up

Outcome Measure Data

Analysis Population Description

All randomized subjects who were exposed to any study lenses evaluated in the study (Full Analysis Set), with non missing data.

Arm/Group Title	MDACL	DACL
Arm/Group Description	MDACL worn for approximately 1 week, Period 1 or Period 2, as randomized	DACL worn for approximately 1 week, Period 1 or Period 2, as randomized
Measure Participants	59	60
Measure eyes	118	120
Day 1 Dispense	-0.04 (0.07)	-0.04 (0.07)
Day 7 Follow-Up	-0.05 (0.07)	-0.05 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MDACL, DACL
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority in VA was declared if the Upper Confidence Limit was less than 0.05.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.00
	Confidence Interval	(1-Sided) 95%; to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.005
	Estimation Comments	test minus control

Adverse Events

Time Frame	Adverse events were collected (observed or reported) for the duration of the individual's participation in the study, approximately 2 weeks.
Adverse Event Reporting Description	An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study lenses. This analysis population includes all subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set).
Arm/Group Title	MDACL		DACL
Arm/Group Description	MDACL worn for approximately 1 week, Period 1 or Period 2, as randomized		DACL worn for approximately 1 week, Period 1 or Period 2, as randomized
All Cause Mortality
	MDACL		DACL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/60 (0%)
Serious Adverse Events
	MDACL		DACL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	MDACL		DACL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/60 (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.