Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04422990
• Collaborator: (none)
• Enrollment: 158
• Locations: 14
• Arms: 2
• Actual Duration (Months): 7.5
• Patients Per Site: 11.3
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of this clinical study is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors	Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses; Device: CLEAR CARE	N/A

Detailed Description

Subjects will be expected to attend 4 office visits: Screening/Baseline/Dispense, Week 1 Follow-up, Month 1 Follow-up, and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3-4 months in this daily wear clinical study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Feb 22, 2021
• Actual Study Completion Date: May 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LID018869 Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.	Device: Lehfilcon A contact lenses; Investigational silicone hydrogel contact lenses; Other Names: LID018869 ; Device: CLEAR CARE; Hydrogen peroxide-based contact lens cleaning and disinfecting solution
Active Comparator: Biofinity Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses will be worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.	Device: Comfilcon A contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: CooperVision® BIOFINITY® Biofinity ; Device: CLEAR CARE; Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Outcome Measures

Primary Outcome Measures

1. Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up [Week 1 Follow-Up]

   Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.

Secondary Outcome Measures

1. Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye at Week 1 Follow-Up [Week 1 Follow-Up]

   Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight. Subjects achieving at least 20/20 Snellen in each eye, left and right, contributed to the analysis.

Eligibility Criteria

Criteria

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

Key Inclusion Criteria:

• Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day;

• Manifest cylinder equal to or less than 0.75 diopter (D) in each eye;

• Best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye;

• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;

• Habitually wearing Biofinity lenses;

• Monovision or multifocal contact lens wearers;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Los Angeles	California	United States	90012
2	Alcon Investigative Site	Novato	California	United States	94945
3	Alcon Investigative Site	Oakland	California	United States	94513
4	Alcon Investigative Site	Oakland	California	United States	94607
5	Alcon Investigative Site	San Francisco	California	United States	94122
6	Alcon Investigative Site	Orlando	Florida	United States	32803
7	Alcon Investigative Site	West Palm Beach	Florida	United States	33405
8	Alcon Investigative Site	Downers Grove	Illinois	United States	60515
9	Alcon Investigative Site	Louisville	Kentucky	United States	40221
10	Alcon Investigative Site	New York	New York	United States	10036
11	Alcon Investigative Site	Cleveland	Ohio	United States	44106
12	Alcon Investigative Site	Boiling Springs	South Carolina	United States	29316
13	Alcon Investigative Site	Plano	Texas	United States	75093
14	Alcon Investigative Site	Wichita Falls	Texas	United States	76308

Sponsors and Collaborators

• Alcon Research

Investigators

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

Study Documents (Full-Text)

• Study Protocol - May 26, 2020
• Statistical Analysis Plan - Apr 28, 2021

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT04422990
• Other Study ID Numbers: CLY935-C012
• First Posted: Jun 9, 2020
• Last Update Posted: Mar 29, 2022
• Last Verified: Mar 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: Vision Correction; Contact Lens
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 14 sites located in the United States.
Pre-assignment Detail	Of the 158 enrolled, 11 subjects were not dispensed study lenses and were exited from the study as screen failures. This reporting group includes all subjects who were dispensed study lenses (147).

Arm/Group Title	Biofinity	LID018869
Arm/Group Description	Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
Period Title: Overall Study
STARTED	50	97
COMPLETED	47	96
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Biofinity	LID018869	Total
Arm/Group Description	Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	Total of all reporting groups
Overall Participants	49	92	141
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.6 (9.7)	33.1 (10.8)	33.2 (10.4)
Sex: Female, Male (Count of Participants)
Female	36 73.5%	61 66.3%	97 68.8%
Male	13 26.5%	31 33.7%	44 31.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	5 5.4%	5 3.5%
Not Hispanic or Latino	49 100%	87 94.6%	136 96.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	12 24.5%	20 21.7%	32 22.7%
Black or African American	0 0%	1 1.1%	1 0.7%
Chinese	31 63.3%	61 66.3%	92 65.2%
Japanese	1 2%	4 4.3%	5 3.5%
Korean	4 8.2%	6 6.5%	10 7.1%
Other Asian	1 2%	0 0%	1 0.7%

Outcome Measures

1. Primary Outcome

Title	Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) at Week 1 Follow-Up
Description	Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Time Frame	Week 1 Follow-Up

Outcome Measure Data

Analysis Population Description

PP: A predefined subset of subjects (those with BCVA of 20/20 or better in each eye at baseline/dispense) from another similar completed registration study, CLY935-C010 (NCT04178720) was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary endpoints. This included 49 subjects from CLY935-C012 and 39 subjects from CLY935-C010 in the Biofinity group and 92 subjects from CLY935-C012 and 78 subjects from CLY935-C010 in the LID018869 group.

Arm/Group Title	Biofinity	LID018869
Arm/Group Description	Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
Measure Participants	88	170
Measure eyes	176	340
Least Squares Mean (Standard Error) [logMAR]	-0.06 (0.00)	-0.06 (0.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Biofinity, LID018869
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority in mean CLCDVA was declared if the upper confidence limit was less than 0.10 logMAR.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -0.01 to 0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least squares mean difference (LID018869 minus Biofinity).

2. Secondary Outcome

Title	Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye at Week 1 Follow-Up
Description	Visual acuity (VA) was assessed for each eye individually with study lenses in place using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight. Subjects achieving at least 20/20 Snellen in each eye, left and right, contributed to the analysis.
Time Frame	Week 1 Follow-Up

Outcome Measure Data

Analysis Population Description

PP: A predefined subset of subjects (those with BCVA of 20/20 or better in each eye at baseline/dispense) from another similar completed registration study, CLY935-C010 (NCT04178720) was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary endpoints. This included 49 subjects from CLY935-C012 and 39 subjects from CLY935-C010 in the Biofinity group and 92 subjects from CLY935-C012 and 78 subjects from CLY935-C010 in the LID018869 group.

Arm/Group Title	Biofinity	LID018869
Arm/Group Description	Comfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.	Lehfilcon A silicone hydrogel contact lenses worn in both eyes during waking hours only. Lenses were worn for a total of 3 months, with monthly planned replacement over the course of the study duration. CLEAR CARE was used for nightly contact lens cleaning and disinfection.
Measure Participants	88	170
Measure eyes	176	340
Number [percentage of subjects]	98.8	97.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Biofinity, LID018869
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Proportion of subjects was used for the statistical analysis. Noninferiority in proportion of subjects achieving CLCDVA 20/20 or better in each eye was declared if the lower confidence limit was greater than -0.10.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in proportion
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 95%; -0.04 to 0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lens difference (LID018869 minus Biofinity)

Adverse Events

Time Frame	Adverse events (AE's) were collected from time of consent to study exit, approximately 3 months.
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. The safety analysis set includes all subjects/eyes exposed to any study lenses evaluated in this study. For treatment-emergent safety analyses, subjects/eyes were categorized under the actual study lenses exposed.
Arm/Group Title	Pre-Treatment		Biofinity Ocular		Biofinity Non-Ocular		LID018869 Ocular		LID018869 Non-Ocular
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 comfilcon A contact lenses		Events reported in this group occurred while exposed to comfilcon A contact lenses		Events reported in this group occurred while exposed to LID018869 contact lenses		Events reported in this group occurred while exposed to LID018869 contact lenses
All Cause Mortality
	Pre-Treatment		Biofinity Ocular		Biofinity Non-Ocular		LID018869 Ocular		LID018869 Non-Ocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/147 (0%)		0/100 (0%)		0/50 (0%)		0/194 (0%)		0/97 (0%)
Serious Adverse Events
	Pre-Treatment		Biofinity Ocular		Biofinity Non-Ocular		LID018869 Ocular		LID018869 Non-Ocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/147 (0%)		0/100 (0%)		0/50 (0%)		0/194 (0%)		0/97 (0%)
Other (Not Including Serious) Adverse Events
	Pre-Treatment		Biofinity Ocular		Biofinity Non-Ocular		LID018869 Ocular		LID018869 Non-Ocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/147 (0%)		0/100 (0%)		0/50 (0%)		0/194 (0%)		0/97 (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.