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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04055519
• Collaborator: (none)
• Enrollment: 36
• Locations: 3
• Arms: 2
• Actual Duration (Months): 2.5
• Patients Per Site: 12
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

The purpose of this study is to obtain on-eye performance data to inform contact lens product development.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors	Device: Lehfilcon A contact lenses; Device: Comfilcon A contact lenses; Device: Multi-purpose disinfection solution	N/A

Detailed Description

Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
• Actual Study Start Date: Sep 19, 2019
• Actual Primary Completion Date: Dec 3, 2019
• Actual Study Completion Date: Dec 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: LID017569, then Biofinity Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.	Device: Lehfilcon A contact lenses; Investigational silicone hydrogel contact lenses; Other Names: LID017569 ; Device: Comfilcon A contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: Biofinity® ; Device: Multi-purpose disinfection solution; Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses; Other Names: OPTI-FREE® RepleniSH®
Other: Biofinity, then LID017569 Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses will be removed nightly for cleaning and disinfection.	Device: Lehfilcon A contact lenses; Investigational silicone hydrogel contact lenses; Other Names: LID017569 ; Device: Comfilcon A contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: Biofinity® ; Device: Multi-purpose disinfection solution; Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses; Other Names: OPTI-FREE® RepleniSH®

Outcome Measures

Primary Outcome Measures

1. Distance VA (logMAR) With Study Lenses [Day 30 after a minimum of 6 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). 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

Inclusion Criteria:

• Sign Informed Consent document.

• Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.

• Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

• Any eye condition or disease or use of medication that contraindicates contact lens wear.

• Eye surgery, irregular cornea, eye injury as specified in the protocol.

• Routinely sleeps in contact lenses at least 1 night per week over the last 3 months prior to enrollment.

• Any use of topical ocular medications, artificial tear or rewetting drops that would require instillation during contact lens wear.

• Habitually wears Biofinity contact lenses.

• Other protocol-specified 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	Memphis	Tennessee	United States	38111

Sponsors and Collaborators

• Alcon Research

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Sep 13, 2019
• Statistical Analysis Plan - Sep 24, 2019

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT04055519
• Other Study ID Numbers: CLY935-C007
• First Posted: Aug 13, 2019
• Last Update Posted: May 13, 2021
• Last Verified: Apr 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
• Keywords provided by Alcon Research: Contact Lenses
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were enrolled at 3 investigative sites located in the US.
Pre-assignment Detail	This reporting group includes all randomized subjects/eyes (36/72) as treated. Note: Two subjects received investigational product misallocations and were exposed to the incorrect study product in the sequence.

Arm/Group Title	LID017569, Then Biofinity	Biofinity, Then LID017569
Arm/Group Description	Lehfilcon A contact lenses worn in Period 1, with comfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection.	Comfilcon A contact lenses worn in Period 1, with lehfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection.
Period Title: First Wear Period (30 Days)
STARTED	16	20
COMPLETED	16	20
NOT COMPLETED	0	0
Period Title: First Wear Period (30 Days)
STARTED	16	20
COMPLETED	16	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	LID017569 and Biofinity contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. Each product was worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection.
Overall Participants	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.1 (5.8)
Sex: Female, Male (Count of Participants)
Female	28 77.8%
Male	8 22.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.8%
Not Hispanic or Latino	35 97.2%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 5.6%
White	34 94.4%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	36 100%

Outcome Measures

1. Primary Outcome

Title	Distance VA (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). 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 30 after a minimum of 6 hours of wear, each product

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study.

Arm/Group Title	LID017569	Biofinity
Arm/Group Description	Lehfilcon A contact lenses worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection.	Comfilcon A contact lenses worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection.
Measure Participants	36	36
Measure eyes	72	72
Mean (Standard Deviation) [logMAR]	-0.13 (0.06)	-0.14 (0.06)

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	Pre-treatment		LID017569 Ocular		LID017569 Nonocular/Systemic		Biofinity Ocular		Biofinity Nonocular/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 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
	Pre-treatment		LID017569 Ocular		LID017569 Nonocular/Systemic		Biofinity Ocular		Biofinity Nonocular/Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/72 (0%)		0/36 (0%)		0/72 (0%)		0/36 (0%)
Serious Adverse Events
	Pre-treatment		LID017569 Ocular		LID017569 Nonocular/Systemic		Biofinity Ocular		Biofinity Nonocular/Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/72 (0%)		0/36 (0%)		0/72 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	Pre-treatment		LID017569 Ocular		LID017569 Nonocular/Systemic		Biofinity Ocular		Biofinity Nonocular/Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/72 (0%)		0/36 (0%)		0/72 (0%)		0/36 (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.