Comparison of Two Daily Disposable Lenses

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04013789
• Collaborator: (none)
• Enrollment: 79
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.9
• Patients Per Site Per Month: 27.6

Study Details

Study Description

Brief Summary

The purpose of this study was to compare the clinical performance of the new DAILIES® AquaComfort PLUS® FreshTech (DACP FreshTech) contact lenses to an already marketed daily disposable contact lens, DAILIES® AquaComfort PLUS® (DACP).

Condition or Disease	Intervention/Treatment	Phase
Refractive Ametropia; Myopia	Device: DACP FreshTech contact lenses; Device: DACP contact lenses	N/A

Detailed Description

Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Two Daily Disposable Lenses
• Actual Study Start Date: Aug 27, 2019
• Actual Primary Completion Date: Nov 22, 2019
• Actual Study Completion Date: Nov 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: DACP FreshTech, then DACP DACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day.	Device: DACP FreshTech contact lenses; Nelfilcon A soft contact lenses with a modified lens design; Other Names: DAILIES® AquaComfort PLUS® FreshTech ; Device: DACP contact lenses; Nelfilcon A soft contact lenses; Other Names: DAILIES® AquaComfort PLUS®
Other: DACP, then DACP FreshTech DACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day.	Device: DACP FreshTech contact lenses; Nelfilcon A soft contact lenses with a modified lens design; Other Names: DAILIES® AquaComfort PLUS® FreshTech ; Device: DACP contact lenses; Nelfilcon A soft contact lenses; Other Names: DAILIES® AquaComfort PLUS®

Outcome Measures

Primary Outcome Measures

1. Mean Distance Visual Acuity (VA) With Study Lenses [Week 1, each product]

   VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least 3 months of soft contact lens wearing experience;

• Wears habitual lenses at least 5 days per week and at least 8 hours per day;

• Uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day;

• Experiences eye fatigue at least once per week attributable to digital device use with habitual lenses;

• Is willing to NOT use rewetting/lubricating drops during the period of study product exposure;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Routinely sleeps in contact lenses;

• Known pregnancy at time of enrollment;

• Binocular vision issues or issues of eye alignment;

• Any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear;

• Use of medications as specified in the protocol;

• Ocular surgery within the past 12 months;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Bloomington	Indiana	United States	47405

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Sr. Clinical Project Lead, Alcon Research

Study Documents (Full-Text)

• Study Protocol - Oct 7, 2019
• Statistical Analysis Plan - Oct 15, 2019

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT04013789
• Other Study ID Numbers: CLD523-P001
• First Posted: Jul 10, 2019
• Last Update Posted: Nov 24, 2020
• Last Verified: Nov 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
• Keywords provided by Alcon Research: eye strain; eye fatigue
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	The study was conducted at a single investigative site in the United States.
Pre-assignment Detail	Of the 79 enrolled subjects, 11 were screen failures and 1 withdrew prior to randomization. This reporting group includes all randomized subjects (67).

Arm/Group Title	DACP FreshTech, Then DACP	DACP, Then DACP FreshTech
Arm/Group Description	DACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day.	DACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day.
Period Title: First Wear Period (1 Week)
STARTED	33	34
COMPLETED	33	34
NOT COMPLETED	0	0
Period Title: First Wear Period (1 Week)
STARTED	32	34
COMPLETED	32	34
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	DACP FreshTech contact lenses and DACP contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
Overall Participants	67
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.4 (3.7)
Sex: Female, Male (Count of Participants)
Female	57 85.1%
Male	10 14.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 7.5%
Not Hispanic or Latino	62 92.5%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	8 11.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 3%
White	54 80.6%
More than one race	0 0%
Unknown or Not Reported	3 4.5%

Outcome Measures

1. Primary Outcome

Title	Mean Distance Visual Acuity (VA) With Study Lenses
Description	VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Time Frame	Week 1, each product

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All randomized subjects (as randomized) who were exposed to any study lenses, not including the optimized habitual and trial fit lenses.

Arm/Group Title	DACP FreshTech	DACP
Arm/Group Description	DACP FreshTech contact lenses worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day	DACP contact lenses worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day
Measure Participants	66	66
Mean (Standard Deviation) [logMAR]	-0.20 (0.06)	-0.22 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DACP FreshTech, DACP
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The noninferiority margin was set at 0.05.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.02
	Confidence Interval	(1-Sided) 95%; to 0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.006
	Estimation Comments	DACP FreshTech minus DACP

Adverse Events

Time Frame	Adverse events were collected from time of consent to study exit, approximately 3 weeks. The safety analysis set included all all randomized subjects (as treated) who were exposed to any study lenses, not including the optimized habitual and trial-fit lenses.
Adverse Event Reporting Description	Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
Arm/Group Title	DACP FreshTech - Ocular		DACP FreshTech - Systemic / Nonocular		DACP - Ocular		DACP - Systemic / Nonocular
Arm/Group Description	Nelfilcon A soft contact lenses with a modified lens design worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 7 days with a new pair of lenses worn each day.		Nelfilcon A soft contact lenses with a modified lens design worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 7 days with a new pair of lenses worn each day.		Nelfilcon A soft contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 7 days with a new pair of lenses worn each day.		Nelfilcon A soft contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 7 days with a new pair of lenses worn each day.
All Cause Mortality
	DACP FreshTech - Ocular		DACP FreshTech - Systemic / Nonocular		DACP - Ocular		DACP - Systemic / Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/134 (0%)		0/67 (0%)		0/132 (0%)		0/66 (0%)
Serious Adverse Events
	DACP FreshTech - Ocular		DACP FreshTech - Systemic / Nonocular		DACP - Ocular		DACP - Systemic / Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/134 (0%)		0/67 (0%)		0/132 (0%)		0/66 (0%)
Other (Not Including Serious) Adverse Events
	DACP FreshTech - Ocular		DACP FreshTech - Systemic / Nonocular		DACP - Ocular		DACP - Systemic / Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/134 (0%)		0/67 (0%)		0/132 (0%)		0/66 (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.