Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04532099
• Collaborator: (none)
• Enrollment: 132
• Locations: 4
• Arms: 3
• Actual Duration (Months): 7.8
• Patients Per Site: 33
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors; Ametropia	Device: Lehfilcon A contact lenses; Device: Senofilcon A contact lenses; Device: Comfilcon A contact lenses; Device: Hydrogen peroxide-based cleaning and disinfecting solution	N/A

Detailed Description

Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits.

Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Part A is a crossover study. Part B is a single group study.Part A is a crossover study. Part B is a single group study.
• Masking: Double (Participant, Investigator)
• Masking Description: Part A is double masked. Part B is single masked (trial subject).
• Primary Purpose: Treatment
• Official Title: Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
• Actual Study Start Date: Sep 9, 2020
• Actual Primary Completion Date: May 4, 2021
• Actual Study Completion Date: May 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: LID018869, then AOHP (Part A) Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.	Device: Lehfilcon A contact lenses; Investigational soft contact lenses for daily wear worn in Part A of the study; Other Names: LID018869 ; Device: Senofilcon A contact lenses; Commercially available soft contact lenses for daily wear worn in Part A of the study; Other Names: AOHP ACUVUE OASYS® with HYDRACLEAR® PLUS ; Device: Hydrogen peroxide-based cleaning and disinfecting solution; For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study; Other Names: CLEAR CARE®
Other: AOHP, then LID018869 (Part A) Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product will be worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.	Device: Lehfilcon A contact lenses; Investigational soft contact lenses for daily wear worn in Part A of the study; Other Names: LID018869 ; Device: Senofilcon A contact lenses; Commercially available soft contact lenses for daily wear worn in Part A of the study; Other Names: AOHP ACUVUE OASYS® with HYDRACLEAR® PLUS ; Device: Hydrogen peroxide-based cleaning and disinfecting solution; For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study; Other Names: CLEAR CARE®
Active Comparator: Biofinity (Part B) Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses will be removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.	Device: Comfilcon A contact lenses; Commercially available soft contact lenses for daily wear worn in Part B of the study; Other Names: CooperVision® Biofinity® ; Device: Hydrogen peroxide-based cleaning and disinfecting solution; For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study; Other Names: CLEAR CARE®

Outcome Measures

Primary Outcome Measures

1. Distance Visual Acuity (VA) (Part A) [Day 30, each study lens type]

   Distance 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. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.

Eligibility Criteria

Criteria

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

Key Inclusion Criteria:

• Sign an approved Informed Consent Form.

• Wear spherical contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.

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

• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Any eye condition or use of medication that contraindicates contact lens wear, as determined by the Investigator.

• History of refractive surgery or plan to have refractive surgery during the study.

• Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.

• Routinely sleeps in contact lenses at least 1 night per week.

• Part A: Current wearer of ACUVUE OASYS® with HYDRACLEAR® PLUS.

• Part B: Current wearer of Biofinity family of contact lenses (comfilcon A).

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigator 6356	Longwood	Florida	United States	32779
2	Alcon Investigator 6565	Maitland	Florida	United States	32751
3	Alcon Investigator 6401	Warwick	Rhode Island	United States	02888
4	Alcon Investigator 6353	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 - Feb 19, 2021
• Statistical Analysis Plan - Mar 8, 2021

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT04532099
• Other Study ID Numbers: CLY935-C020
• First Posted: Aug 31, 2020
• Last Update Posted: May 3, 2022
• Last Verified: May 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: Refractive Errors; Hydrogen Peroxide

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 4 investigative sites located in the United States.

Arm/Group Title	LID018869, Then AOHP (Part A)	AOHP, Then LID018869 (Part A)	Biofinity (Part B)
Arm/Group Description	Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.	Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.	Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
Period Title: First Wear Period (30 Days)
STARTED	33	33	66
COMPLETED	32	33	66
NOT COMPLETED	1	0	0
Period Title: First Wear Period (30 Days)
STARTED	32	33	0
COMPLETED	32	33	0
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	LID018869, Then AOHP (Part A)	AOHP, Then LID018869 (Part A)	Biofinity (Part B)	Total
Arm/Group Description	Lehfilcon A contact lenses worn first, followed by senofilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.	Senofilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of each wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.	Comfilcon A contact lenses worn bilaterally (in both eyes) for approximately 30 days, with a scheduled visit at approximately Day 15 of the wear period. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.	Total of all reporting groups
Overall Participants	33	33	66	132
Age, Customized (Count of Participants)
18-64 years	33 100%	33 100%	66 100%	132 100%
Equal to or greater than 65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	26 78.8%	20 60.6%	49 74.2%	95 72%
Male	7 21.2%	13 39.4%	17 25.8%	37 28%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3%	1 3%	5 7.6%	7 5.3%
Not Hispanic or Latino	32 97%	32 97%	61 92.4%	125 94.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	2 6.1%	0 0%	1 1.5%	3 2.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	1 3%	3 4.5%	4 3%
White	31 93.9%	32 97%	62 93.9%	125 94.7%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Distance Visual Acuity (VA) (Part A)
Description	Distance 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. No formal hypothesis testing was predefined for the primary endpoint. The primary endpoint was prespecified for Part A only.
Time Frame	Day 30, each study lens type

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	LID018869 (Part A)	AOHP (Part A)
Arm/Group Description	Lehfilcon A contact lenses worn during Period 1 or Period 2, as randomized, for approximately 30 days. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.	Senofilcon A contact lenses worn during Period 1 or Period 2, as randomized, for approximately 30 days. Lenses were removed nightly for cleaning and disinfection with CLEAR CARE contact lens solution.
Measure Participants	66	65
Measure eyes	132	130
Mean (Standard Deviation) [logMAR]	-0.12 (0.09)	-0.12 (0.09)

Adverse Events

Time Frame	Adverse events (AE's) were collected from time of consent to study exit, approximately 8 weeks for subjects enrolled in Part A and approximately 4 weeks for subjects enrolled in Part B.
Adverse Event Reporting Description	An AE was defined at any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of pretreatment and non-ocular AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Arm/Group Title	Pretreatment Part A		LID018869 Ocular (Part A)		LID018869 Nonocular		AOHP Ocular		AOHP Nonocular		Pretreatment Part B		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 senofilcon A contact lenses.		Events reported in this group occurred while exposed to senofilcon A contact lenses.		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.
All Cause Mortality
	Pretreatment Part A		LID018869 Ocular (Part A)		LID018869 Nonocular		AOHP Ocular		AOHP Nonocular		Pretreatment Part B		Biofinity Ocular		Biofinity Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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%)		0/66 (0%)		0/132 (0%)		0/66 (0%)
Serious Adverse Events
	Pretreatment Part A		LID018869 Ocular (Part A)		LID018869 Nonocular		AOHP Ocular		AOHP Nonocular		Pretreatment Part B		Biofinity Ocular		Biofinity Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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%)		0/66 (0%)		0/132 (0%)		0/66 (0%)
Other (Not Including Serious) Adverse Events
	Pretreatment Part A		LID018869 Ocular (Part A)		LID018869 Nonocular		AOHP Ocular		AOHP Nonocular		Pretreatment Part B		Biofinity Ocular		Biofinity Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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%)		0/66 (0%)		0/132 (0%)		0/66 (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.