Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04207749
• Collaborator: (none)
• Enrollment: 249
• Locations: 18
• Arms: 2
• Actual Duration (Months): 10.8
• Patients Per Site: 13.8
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The purpose of this clinical study is to assess 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 with frequent replacement.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors; Myopia; Hyperopia	Device: LID015385 contact lenses; Device: Comfilcon A contact lenses; Device: CLEAR CARE	N/A

Detailed Description

Subjects will 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 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 249 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens
• Actual Study Start Date: Jan 22, 2020
• Actual Primary Completion Date: Dec 17, 2020
• Actual Study Completion Date: Dec 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LID015385 LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.	Device: LID015385 contact lenses; Investigational soft contact lenses; Device: CLEAR CARE; Hydrogen peroxide-based cleaning and disinfecting solution
Active Comparator: Biofinity Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE will be used for nightly cleaning and disinfection.	Device: Comfilcon A contact lenses; Commercially available soft contact lenses; Other Names: BIOFINITY® ; Device: CLEAR CARE; Hydrogen peroxide-based cleaning and disinfecting solution

Outcome Measures

Primary Outcome Measures

1. Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009) [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 (CLL949-C018 + CLL949-C009) [Week 1 Follow-Up, at least 4 hours after lens insertion]

   Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight.

Eligibility Criteria

Criteria

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

Key Inclusion Criteria:

• Understand and sign an IRB/IEC approved Informed Consent form.

• Willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol.

• Successful wear of frequent replacement, spherical, daily wear 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 ≤ 0.75 diopter (D) in each eye.

• Best spectacle corrected visual acuity 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.

• Monovision contact lens wear.

• Any habitual wear of Biofinity lenses.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigator 8103	Glendale	Arizona	United States	85308
2	Alcon Investigator 8101	Brentwood	California	United States	94513
3	Alcon Investigator 8102	Irvine	California	United States	92618
4	Alcon Investigator 8135	Los Angeles	California	United States	90012
5	Alcon Investigator 8108	Novato	California	United States	94945
6	Alcon Investigator 8062	Oakland	California	United States	94607
7	Alcon Investigator 8109	San Francisco	California	United States	94127
8	Alcon Investigator 6565	Maitland	Florida	United States	32751
9	Alcon Investigator 6355	Orlando	Florida	United States	32803
10	Alcon Investigator 8115	Norcross	Georgia	United States	30071
11	Alcon Investigator 6567	Pittsburg	Kansas	United States	66762
12	Alcon Investigator 8063	Brighton	Massachusetts	United States	02135
13	Alcon Investigator 8100	New York	New York	United States	10036
14	Alcon Investigator 4817	Cleveland	Ohio	United States	44106
15	Alcon Investigator 6313	Powell	Ohio	United States	43065
16	Alcon Investigator 6401	Warwick	Rhode Island	United States	02888
17	Alcon Investigator 6353	Memphis	Tennessee	United States	38111
18	Alcon Investigator 8114	Plano	Texas	United States	75093

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 13, 2020
• Statistical Analysis Plan - Jan 5, 2021

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT04207749
• Other Study ID Numbers: CLL949-C018
• First Posted: Dec 23, 2019
• Last Update Posted: Feb 2, 2022
• Last Verified: Jan 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
• Additional relevant MeSH terms: Refractive Errors; Hyperopia

Study Results

Participant Flow

Recruitment Details	This study was conducted at 18 investigative sites located in the United States.
Pre-assignment Detail	Of the 249 participants enrolled in this study, 15 were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects/eyes (234/468).

Arm/Group Title	Biofinity	LID015385
Arm/Group Description	Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.	LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.
Period Title: Overall Study
STARTED	78	156
COMPLETED	74	149
NOT COMPLETED	4	7

Baseline Characteristics

Arm/Group Title	Biofinity	LID015385	Total
Arm/Group Description	Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.	LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.	Total of all reporting groups
Overall Participants	75	145	220
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.7 (8.2)	31.3 (9.1)	31.8 (8.8)
Sex: Female, Male (Count of Participants)
Female	52 69.3%	105 72.4%	157 71.4%
Male	23 30.7%	40 27.6%	63 28.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 4%	6 4.1%	9 4.1%
Not Hispanic or Latino	72 96%	139 95.9%	211 95.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	30 40%	65 44.8%	95 43.2%
Black or African American	2 2.7%	1 0.7%	3 1.4%
Chinese	32 42.7%	64 44.1%	96 43.6%
Japanese	6 8%	7 4.8%	13 5.9%
Korean	4 5.3%	7 4.8%	11 5%
Other Asian	0 0%	1 0.7%	1 0.5%
Other	1 1.3%	0 0%	1 0.5%
Region of Enrollment (participants) [Number]
United States	75 100%	145 100%	220 100%

Outcome Measures

1. Primary Outcome

Title	Least Squares Mean Contact Lens Corrected Distance Visual Acuity (CLCDVA) in Each Eye (CLL949-C018 + CLL949-C009)
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 data from another similar completed study, CLL949-C009 (NCT03920280), was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary outcome measures. The subset of subjects from CLL949-C009 that contributed data were those with Best-Corrected Visual Acuity (BCVA) of 20/20 or better in each eye at the Screening/Baseline/Dispense Visit.

Arm/Group Title	Biofinity	LID015385
Arm/Group Description	Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.	LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.
Measure Participants	106	200
Measure eyes	212	400
Least Squares Mean (Standard Error) [logMAR]	-0.06 (0.00)	-0.05 (0.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Biofinity, LID015385
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Noninferiority in 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	0.01
	Confidence Interval	(2-Sided) 95%; -0.00 to 0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least squares mean difference (LID015385 minus Biofinity).

2. Secondary Outcome

Title	Percentage of Subjects Achieving CLCDVA 20/20 or Better in Each Eye (CLL949-C018 + CLL949-C009)
Description	Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen, with 20/20 Snellen visual acuity considered normal distance eyesight.
Time Frame	Week 1 Follow-Up, at least 4 hours after lens insertion

Outcome Measure Data

Analysis Population Description

PP. A predefined subset of data from another similar completed study, CLL949-C009 (NCT03920280), was combined with this study to attain adequate power for the planned hypothesis testing of the primary and secondary outcome measures. The subset of subjects from CLL949-C009 that contributed data were those with Best-Corrected Visual Acuity (BCVA) of 20/20 or better in each eye at the Screening/Baseline/Dispense Visit.

Arm/Group Title	Biofinity	LID015385
Arm/Group Description	Comfilcon A contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.	LID015385 contact lenses worn at least 5 days per week and 8 hours per day in a daily wear modality (that is, not worn while sleeping) for approximately 3 months. CLEAR CARE was used for nightly cleaning and disinfection.
Measure Participants	106	200
Number [percentage of subjects]	98.1	97.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Biofinity, LID015385
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Proportion of subjects is presented. 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%; -0.06 to 0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments	Lens difference (LID015385 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 in the corresponding lens sequence.
Arm/Group Title	Pretreatment		Biofinity - Ocular		Biofinity - Nonocular		LID015385 - Ocular		LID015385 - Nonocular
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 LID015385 contact lenses		Events reported in this group occurred while exposed to LID015385 contact lenses
All Cause Mortality
	Pretreatment		Biofinity - Ocular		Biofinity - Nonocular		LID015385 - Ocular		LID015385 - Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/234 (0%)		0/156 (0%)		0/78 (0%)		0/312 (0%)		0/156 (0%)
Serious Adverse Events
	Pretreatment		Biofinity - Ocular		Biofinity - Nonocular		LID015385 - Ocular		LID015385 - Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/234 (0%)		0/156 (0%)		0/78 (0%)		0/312 (0%)		0/156 (0%)
Other (Not Including Serious) Adverse Events
	Pretreatment		Biofinity - Ocular		Biofinity - Nonocular		LID015385 - Ocular		LID015385 - Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/234 (0%)		0/156 (0%)		0/78 (0%)		0/312 (0%)		0/156 (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.