Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04476784
• Collaborator: (none)
• Enrollment: 66
• Locations: 5
• Arms: 2
• Actual Duration (Months): 3.1
• Patients Per Site: 13.2
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the clinical performance of an investigational contact lens over 30 days of daily wear.

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

Detailed Description

Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 60 days (30 days for each product).

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
• Actual Study Start Date: Aug 17, 2020
• Actual Primary Completion Date: Nov 18, 2020
• Actual Study Completion Date: Nov 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: LID018869, then Biofinity Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.	Device: Lehfilcon A contact lenses; Investigational silicone hydrogel contact lenses; Other Names: LID018869 ; Device: Comfilcon A contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: CooperVision® BIOFINITY® Biofinity ; Device: CLEAR CARE; Hydrogen peroxide-based cleaning and disinfecting solution
Other: Biofinity, then LID018869 Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE will be used for nightly cleaning and disinfection.	Device: Lehfilcon A contact lenses; Investigational silicone hydrogel contact lenses; Other Names: LID018869 ; Device: Comfilcon A contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: CooperVision® BIOFINITY® Biofinity ; Device: CLEAR CARE; Hydrogen peroxide-based cleaning and disinfecting solution

Outcome Measures

Primary Outcome Measures

1. Mean Distance Visual Acuity (logMAR) With Study Lenses [Day 1, Day 30 after 6-8 hours of wear, each product]

   Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

Eligibility Criteria

Criteria

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

Key Inclusion Criteria:

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

• Willing and able to attend all scheduled study visits as required by the protocol;

• Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day;

• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current or prior Biofinity contact lens wearer in the past 3 months;

• Monovision contact lens wearer;

• Other protocol-defined 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	Bloomington	Illinois	United States	61704
3	Alcon Investigative Site	Pittsburg	Kansas	United States	66762
4	Alcon Investigative Site	Shawnee Mission	Kansas	United States	66204
5	Alcon Investigative Site	Memphis	Tennessee	United States	38111

Sponsors and Collaborators

• Alcon Research

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Jul 9, 2020
• Statistical Analysis Plan - Dec 2, 2020

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT04476784
• Other Study ID Numbers: CLY935-C013
• First Posted: Jul 20, 2020
• Last Update Posted: Oct 26, 2021
• Last Verified: Sep 1, 2021

• 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: Myopia

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled at 5 investigative sites located in the United States.
Pre-assignment Detail	This reporting group includes all subjects/eyes (66/132) exposed to any study lenses evaluated in this study as treated (Safety Analysis Set)

Arm/Group Title	LID018869, Then Biofinity	Biofinity, Then LID018869
Arm/Group Description	Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.	Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.
Period Title: First Wear Period (30 Days ± 2 Days)
STARTED	31	35
COMPLETED	30	35
NOT COMPLETED	1	0
Period Title: First Wear Period (30 Days ± 2 Days)
STARTED	30	35
COMPLETED	30	35
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	LID018869, Then Biofinity	Biofinity, Then LID018869	Total
Arm/Group Description	Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.	Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.	Total of all reporting groups
Overall Participants	31	35	66
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.6 (8.0)	33.7 (8.7)	33.2 (8.3)
Sex: Female, Male (Count of Participants)
Female	24 77.4%	28 80%	52 78.8%
Male	7 22.6%	7 20%	14 21.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	31 100%	35 100%	66 100%
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%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 3.2%	0 0%	1 1.5%
White	30 96.8%	34 97.1%	64 97%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 2.9%	1 1.5%
Region of Enrollment (participants) [Number]
United States	31 100%	35 100%	66 100%

Outcome Measures

1. Primary Outcome

Title	Mean Distance Visual Acuity (logMAR) With Study Lenses
Description	Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Time Frame	Day 1, Day 30 after 6-8 hours of wear, each product

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study.

Arm/Group Title	LID018869	Biofinity
Arm/Group Description	Lehfilcon A contact lenses worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.	Comfilcon A contact lenses worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection.
Measure Participants	66	65
Measure eyes	132	130
Day 1	-0.11 (0.08)	-0.13 (0.08)
Day 30, after 6-8 hours of wear	-0.12 (0.07)	-0.13 (0.08)

Adverse Events

Time Frame	Adverse events (AE's) were collected from time of consent to study exit, approximately 60 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. 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		LID018869 - Ocular		LID018869 - Nonocular		Biofinity - Ocular		Biofinity - 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 lehfilcon A contact lenses		Events reported in this group occurred while exposed to lehfilcon 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 comfilcon A contact lenses
All Cause Mortality
	Pretreatment		LID018869 - Ocular		LID018869 - Nonocular		Biofinity - Ocular		Biofinity - Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/132 (0%)		0/66 (0%)		0/130 (0%)		0/65 (0%)
Serious Adverse Events
	Pretreatment		LID018869 - Ocular		LID018869 - Nonocular		Biofinity - Ocular		Biofinity - Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/132 (0%)		0/66 (0%)		0/130 (0%)		0/65 (0%)
Other (Not Including Serious) Adverse Events
	Pretreatment		LID018869 - Ocular		LID018869 - Nonocular		Biofinity - Ocular		Biofinity - Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/132 (0%)		0/66 (0%)		0/130 (0%)		0/65 (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.