Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04631796
• Collaborator: (none)
• Enrollment: 36
• Locations: 3
• Arm: 1
• Actual Duration (Days): 28
• Patients Per Site: 12
• Patients Per Site Per Month: 13

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 2 weeks of daily wear.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors	Device: Lehfilcon A contact lenses; Device: Multipurpose disinfection solution	N/A

Detailed Description

Participants will attend a Screening visit, a Dispense visit (0 to 4 days later), and a follow-up visit approximately 2 weeks after the Dispense visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens
• Actual Study Start Date: Dec 3, 2020
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LID020098 Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses will be removed nightly for cleaning and disinfection.	Device: Lehfilcon A contact lenses; Silicone hydrogel contact lenses with investigational coating; Other Names: LID020098 ; Device: Multipurpose disinfection solution; Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses; Other Names: OPTI-FREE® RepleniSH®

Outcome Measures

Primary Outcome Measures

1. Front Surface Wettability, by Category [Dispense; Week 2 Follow-up]

   Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Understand and sign an Informed Consent that has been approved by an Institutional Review Board.

• 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.

• Willing to stop wearing habitual contact lenses for the duration of study participation.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any condition that contraindicates contact lens wear, as determined by the Investigator.

• Any use of systemic or ocular medications 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.

• Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.

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

• Monovision or multifocal contact lens wear.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Orlando	Florida	United States	32803
2	Alcon Investigative Site	Bloomington	Illinois	United States	61704
3	Alcon Investigative Site	Powell	Ohio	United States	43065

Sponsors and Collaborators

• Alcon Research

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Oct 28, 2020
• Statistical Analysis Plan - Nov 19, 2020

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT04631796
• Other Study ID Numbers: CLY935-E006
• First Posted: Nov 17, 2020
• Last Update Posted: Jan 12, 2022
• Last Verified: Dec 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: Vision; Contact lenses
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 3 investigative sites located in the United States.
Pre-assignment Detail	Of the 36 enrolled, 1 subject was exited from the study prior to product exposure as a screen failure. This reporting group includes all subjects/eyes exposed to any study lenses evaluated in this study, except for the lenses used with the purpose of power optimization (Safety Analysis Set).

Arm/Group Title	LID020098
Arm/Group Description	Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses were removed nightly for cleaning and disinfection.
Period Title: Overall Study
STARTED	35
COMPLETED	35
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	LID020098
Arm/Group Description	Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses were removed nightly for cleaning and disinfection.
Overall Participants	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.4 (9.0)
Sex: Female, Male (Count of Participants)
Female	21 60%
Male	14 40%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 11.4%
Not Hispanic or Latino	31 88.6%
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	1 2.9%
White	34 97.1%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	35 100%

Outcome Measures

1. Primary Outcome

Title	Front Surface Wettability, by Category
Description	Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.
Time Frame	Dispense; Week 2 Follow-up

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	LID020098
Arm/Group Description	Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses were removed nightly for cleaning and disinfection.
Measure Participants	35
Measure eyes	70
Dispense, Grade 0	70
Dispense, Grade 1	0
Dispense, Grade 2	0
Dispense, Grade 3	0
Dispense, Grade 4	0
Week 2 Follow-up, Grade 0	70
Week 2 Follow-up, Grade 1	0
Week 2 Follow-up, Grade 2	0
Week 2 Follow-up, Grade 3	0
Week 2 Follow-up, Grade 4	0

Adverse Events

Time Frame	Adverse events (AE's) were collected from time of consent to study exit, approximately 2 weeks.
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 subjects/eyes exposed to any study lenses evaluated in this study, except for the lenses used with the purpose of power optimization.
Arm/Group Title	Pretreatment		LID020098 Ocular		LID020098 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 the study contact lenses		Events reported in this group occurred while exposed to the study contact lenses
All Cause Mortality
	Pretreatment		LID020098 Ocular		LID020098 Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/70 (0%)		0/35 (0%)
Serious Adverse Events
	Pretreatment		LID020098 Ocular		LID020098 Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/70 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Pretreatment		LID020098 Ocular		LID020098 Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/70 (0%)		2/35 (5.7%)
Infections and infestations
COVID-19	0/35 (0%)		0/70 (0%)		2/35 (5.7%)

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.