Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03920280
• Collaborator: (none)
• Enrollment: 120
• Locations: 8
• Arms: 2
• Actual Duration (Months): 4.5
• Patients Per Site: 15
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

The purpose of this clinical study is to demonstrate 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: LID015385 contact lenses; Device: Comfilcon A soft contact lenses; Device: CLEAR CARE	N/A

Detailed Description

Subjects will be randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens
• Actual Study Start Date: May 22, 2019
• Actual Primary Completion Date: Oct 5, 2019
• Actual Study Completion Date: Oct 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LID015385 LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.	Device: LID015385 contact lenses; Investigational silicone hydrogel contact lenses; Device: CLEAR CARE; Hydrogen peroxide-based cleaning and disinfecting system
Active Comparator: Biofinity Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses will be removed nightly for cleaning with CLEAR CARE.	Device: Comfilcon A soft contact lenses; Commercially available silicone hydrogel contact lenses; Other Names: Biofinity ; Device: CLEAR CARE; Hydrogen peroxide-based cleaning and disinfecting system

Outcome Measures

Primary Outcome Measures

1. Distance Visual Acuity (VA) With Study Lenses - Completed Eyes [Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit)]

   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 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. No formal hypothesis testing was planned.

2. Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes [Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)]

   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 and converted to the logarithm minimum angle of resolution (logMAR) scale. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values 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:

• 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 ≤ 0.75 diopter (D) in each eye.

• Other protocol-specified 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 wearers.

• Habitually wearing Biofinity® lenses.

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigator 6565	Maitland	Florida	United States	32751
2	Alcon Investigator 6355	Orlando	Florida	United States	32803
3	Alcon Investigator 6291	Pensacola	Florida	United States	32503
4	Alcon Investigator 3950	Bloomington	Illinois	United States	61704
5	Alcon Investigator 6567	Pittsburg	Kansas	United States	66762
6	Alcon Investigator 6313	Powell	Ohio	United States	43065
7	Alcon Investigator 6401	Warwick	Rhode Island	United States	02888
8	Alcon Investigator 6353	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 - Mar 22, 2019
• Statistical Analysis Plan - Apr 19, 2019

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT03920280
• Other Study ID Numbers: CLL949-C009
• First Posted: Apr 18, 2019
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 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
• Keywords provided by Alcon Research: Contact Lens; Daily Wear; Vision Correction
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 8 investigative sites located in the United States.
Pre-assignment Detail	Of the 120 subjects enrolled, 1 was exited from the study prior to randomization as a screen failure. This reporting group includes all enrolled and dispensed subjects (119).

Arm/Group Title	Biofinity	LID015385
Arm/Group Description	Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.	LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
Period Title: Overall Study
STARTED	41	78
COMPLETED	38	72
NOT COMPLETED	3	6

Baseline Characteristics

Arm/Group Title	Biofinity	LID015385	Total
Arm/Group Description	Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.	LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.	Total of all reporting groups
Overall Participants	41	78	119
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.3 (7.7)	32.9 (7.7)	32.4 (7.7)
Sex: Female, Male (Count of Participants)
Female	28 68.3%	63 80.8%	91 76.5%
Male	13 31.7%	15 19.2%	28 23.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.4%	4 5.1%	5 4.2%
Not Hispanic or Latino	40 97.6%	74 94.9%	114 95.8%
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%	1 1.3%	1 0.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	6 7.7%	6 5%
White	39 95.1%	67 85.9%	106 89.1%
More than one race	1 2.4%	0 0%	1 0.8%
Unknown or Not Reported	1 2.4%	4 5.1%	5 4.2%
Region of Enrollment (participants) [Number]
United States	41 100%	78 100%	119 100%

Outcome Measures

1. Primary Outcome

Title	Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
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 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. No formal hypothesis testing was planned.
Time Frame	Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up/Exit (at least 4 hours after lens insertion at each follow-up assessment visit)

Outcome Measure Data

Analysis Population Description

This analysis population includes all enrolled and dispensed subjects/eyes that completed the study.

Arm/Group Title	Biofinity	LID015385
Arm/Group Description	Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.	LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
Measure Participants	38	72
Measure eyes	76	144
Day 1 Dispense	-0.06 (0.06)	-0.06 (0.06)
Week 1 Follow-up	-0.06 (0.06)	-0.05 (0.06)
Week 2 Follow-up	-0.06 (0.06)	-0.06 (0.06)
Month 1 Follow-up	-0.06 (0.06)	-0.05 (0.06)
Month 2 Follow-up	-0.05 (0.06)	-0.04 (0.06)
Month 3 Follow-up/Exit	-0.05 (0.06)	-0.05 (0.06)

2. Primary Outcome

Title	Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
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 and converted to the logarithm minimum angle of resolution (logMAR) scale. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis testing was planned.
Time Frame	Day 1 Dispense; Week 1 Follow-up; Week 2 Follow-up; Month 1 Follow-up; Month 2 Follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)

Outcome Measure Data

Analysis Population Description

This analysis population includes all enrolled and dispensed subjects/eyes that discontinued the study early.

Arm/Group Title	Biofinity	LID015385
Arm/Group Description	Comfilcon A contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.	LID015385 contact lenses worn in both eyes during waking hours only for at least 8 hours per day and 5 days per week over a 3-month exposure period. Lenses were removed nightly for cleaning with CLEAR CARE.
Measure Participants	3	6
Measure eyes	6	12
Day 1 Dispense	-0.04 (0.06)	-0.06 (0.07)
Week 1 Follow-up	-0.02 (0.05)	-0.06 (0.07)
Week 2 Follow-up	-0.04 (0.06)	-0.05 (0.06)
Month 1 Follow-up	0.00 (0.00)	-0.12 (0.00)
Month 2 Follow-up	-0.12 (0.00)

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. This analysis population includes all enrolled and dispensed subjects.
Arm/Group Title	Pretreatment		Biofinity - Ocular		Biofinity - Nonocular/Systemic		LID015385 - Ocular		LID015385 - 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 the comfilcon A contact lenses		Events reported in this group occurred while exposed to the comfilcon A contact lenses		Events reported in this group occurred while exposed to the LID015385 contact lenses		Events reported in this group occurred while exposed to the LID015385 contact lenses
All Cause Mortality
	Pretreatment		Biofinity - Ocular		Biofinity - Nonocular/Systemic		LID015385 - Ocular		LID015385 - Nonocular/Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/119 (0%)		0/82 (0%)		0/41 (0%)		0/156 (0%)		0/78 (0%)
Serious Adverse Events
	Pretreatment		Biofinity - Ocular		Biofinity - Nonocular/Systemic		LID015385 - Ocular		LID015385 - Nonocular/Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/119 (0%)		1/82 (1.2%)		0/41 (0%)		0/156 (0%)		0/78 (0%)
Eye disorders
Ulcerative keratitis	0/119 (0%)		1/82 (1.2%)		0/41 (0%)		0/156 (0%)		0/78 (0%)
Other (Not Including Serious) Adverse Events
	Pretreatment		Biofinity - Ocular		Biofinity - Nonocular/Systemic		LID015385 - Ocular		LID015385 - Nonocular/Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/119 (0%)		0/82 (0%)		0/41 (0%)		0/156 (0%)		0/78 (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.