Clinical Comparison of Two Daily Disposable Contact Lenses

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04865354
• Collaborator: (none)
• Enrollment: 170
• Locations: 8
• Arms: 2
• Actual Duration (Months): 1.3
• Patients Per Site: 21.3
• Patients Per Site Per Month: 15.8

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the clinical performance of PRECISION1™ contact lenses to Clariti® 1 day contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors	Device: Verofilcon A contact lenses; Device: Somofilcon A contact lenses	N/A

Detailed Description

Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. The total duration of subject participation will be up to 22 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Comparison of Two Daily Disposable Contact Lenses
• Actual Study Start Date: May 17, 2021
• Actual Primary Completion Date: Jun 27, 2021
• Actual Study Completion Date: Jun 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: PRECISION1, then Clariti 1-Day Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.	Device: Verofilcon A contact lenses; Spherical soft contact lenses for daily disposable wear; Other Names: PRECISION1 ; Device: Somofilcon A contact lenses; Spherical soft contact lenses for daily disposable wear; Other Names: Clariti 1-Day
Other: Clariti 1-Day, then PRECISION1 Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 days in a daily disposable modality.	Device: Verofilcon A contact lenses; Spherical soft contact lenses for daily disposable wear; Other Names: PRECISION1 ; Device: Somofilcon A contact lenses; Spherical soft contact lenses for daily disposable wear; Other Names: Clariti 1-Day

Outcome Measures

Primary Outcome Measures

1. Least Squares Mean Distance VA (logMAR) With Study Lenses [Day 8, each study lens type]

   Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.

Eligibility Criteria

Criteria

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

Key Inclusion Criteria

• Successful wearer of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.

• Possess spectacles and willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed.

• Willing to wear contact lenses for at least 16 hours on one of the days (day prior to each week 1 visit).

• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers.

• Any monovision and multifocal lens wearers.

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigator 8106	San Francisco	California	United States	94127
2	Alcon Investigator 6565	Maitland	Florida	United States	32751
3	Alcon Investigator 6418	Tallahassee	Florida	United States	32308
4	Alcon Investigator 6614	Franklin Park	Illinois	United States	60131
5	Alcon Investigator 6645	Shawnee Mission	Kansas	United States	66204
6	Alcon Investigator 6402	Medina	Minnesota	United States	55340
7	Alcon Investigator 8046	Granville	Ohio	United States	43023
8	Alcon Investigator 8028	Wichita Falls	Texas	United States	76308

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: CDMA Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study Documents (Full-Text)

• Study Protocol - Apr 10, 2021
• Statistical Analysis Plan - May 4, 2021

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT04865354
• Other Study ID Numbers: CLE383-P005
• First Posted: Apr 29, 2021
• Last Update Posted: Jul 6, 2022
• Last Verified: Jun 1, 2022

• 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 Lenses; Disposable
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	This study was conducted at 8 investigative sites in the United States.
Pre-assignment Detail	Of the 170 enrolled, 3 subjects were exited prior to randomization as screen failures. This reporting group includes all randomized subjects (167).

Arm/Group Title	PRECISION1, Then Clariti 1-Day	Clariti 1-Day, Then PRECISION1
Arm/Group Description	Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 days in a daily disposable modality.	Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 days in a daily disposable modality.
Period Title: First Wear Period (8 Days)
STARTED	83	84
COMPLETED	82	83
NOT COMPLETED	1	1
Period Title: First Wear Period (8 Days)
STARTED	82	83
COMPLETED	81	83
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	PRECISION1, Then Clariti 1-Day	Clariti 1-Day, Then PRECISION1	Total
Arm/Group Description	Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 days in a daily disposable modality.	Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 days in a daily disposable modality.	Total of all reporting groups
Overall Participants	83	84	167
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.3 (8.9)	31.4 (7.5)	31.4 (8.2)
Sex: Female, Male (Count of Participants)
Female	54 65.1%	62 73.8%	116 69.5%
Male	29 34.9%	22 26.2%	51 30.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 6%	8 9.5%	13 7.8%
Not Hispanic or Latino	78 94%	76 90.5%	154 92.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	69 83.1%	67 79.8%	136 81.4%
Black or African American	1 1.2%	3 3.6%	4 2.4%
Asian	12 14.5%	13 15.5%	25 15%
Other	1 1.2%	1 1.2%	2 1.2%
Region of Enrollment (participants) [Number]
United States	83 100%	84 100%	167 100%

Outcome Measures

1. Primary Outcome

Title	Least Squares Mean Distance VA (logMAR) With Study Lenses
Description	Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Time Frame	Day 8, each study lens type

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study with non-missing response (eye)

Arm/Group Title	PRECISION1	Clariti 1-Day
Arm/Group Description	Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 days in a daily disposable modality	Somofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 days in a daily disposable modality
Measure Participants	164	164
Measure eyes	328	328
Least Squares Mean (Standard Error) [logMAR]	-0.119 (0.0055)	-0.122 (0.0055)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PRECISION1, Clariti 1-Day
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority to be concluded if least squares means difference upper confidence limit is less than 0.05.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.003
	Confidence Interval	(1-Sided) 95%; to 0.009
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0034
	Estimation Comments	Difference = PRECISION1 minus Clariti 1-Day

Adverse Events

Time Frame	Adverse events (AE's) were collected from time of consent to study exit, up to 22 days.
Adverse Event Reporting Description	AE's 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 participants. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study. Note: One subject (2 eyes) wore PRECISION1 in both periods and did not wear Clariti 1-Day.
Arm/Group Title	Pretreatment		PRECISION1 Ocular		PRECISION1 Systemic		Clariti 1-Day Ocular		Clariti 1-Day Systemic
Arm/Group Description	Events reported in this group occurred prior to exposure to the study contact lenses		Events reported in this group occurred while exposed to the verofilcon A contact lenses		Events reported in this group occurred while exposed to the verofilcon A contact lenses		Events reported in this group occurred while exposed to the somofilcon A contact lenses		Events reported in this group occurred while exposed to the somofilcon A contact lenses
All Cause Mortality
	Pretreatment		PRECISION1 Ocular		PRECISION1 Systemic		Clariti 1-Day Ocular		Clariti 1-Day Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/167 (0%)		0/334 (0%)		0/167 (0%)		0/332 (0%)		0/166 (0%)
Serious Adverse Events
	Pretreatment		PRECISION1 Ocular		PRECISION1 Systemic		Clariti 1-Day Ocular		Clariti 1-Day Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/167 (0%)		0/334 (0%)		0/167 (0%)		0/332 (0%)		0/166 (0%)
Other (Not Including Serious) Adverse Events
	Pretreatment		PRECISION1 Ocular		PRECISION1 Systemic		Clariti 1-Day Ocular		Clariti 1-Day Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/167 (0%)		0/334 (0%)		0/167 (0%)		0/332 (0%)		0/166 (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.