Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04702984
• Collaborator: (none)
• Enrollment: 39
• Locations: 3
• Arm: 1
• Actual Duration (Months): 1.2
• Patients Per Site: 13
• Patients Per Site Per Month: 11

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 7 days of daily wear.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors	Device: LID021201 contact lenses; Device: OPTI-FREE multipurpose solution	N/A

Detailed Description

Participants will attend a Screening visit, a Dispense visit, and a Week 1 Follow-up/exit visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Lens will be provided with investigational product labeling
• Primary Purpose: Treatment
• Official Title: Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens
• Actual Study Start Date: Jan 21, 2021
• Actual Primary Completion Date: Feb 26, 2021
• Actual Study Completion Date: Feb 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LID021201 LID021201 contact lenses worn in both eyes for 7 days. Lenses will be removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.	Device: LID021201 contact lenses; Investigational silicone hydrogel sphere contact lenses for frequent replacement daily wear; Device: OPTI-FREE multipurpose 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 1 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, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, 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 daily wear frequent replacement 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.

• Wears 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.

• Other protocol-defined 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 6353	Memphis	Tennessee	United States	38111
3	Alcon Investigator 8028	Wichita Falls	Texas	United States	76308

Sponsors and Collaborators

• Alcon Research

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Dec 11, 2020
• Statistical Analysis Plan - Jan 13, 2021

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT04702984
• Other Study ID Numbers: CLL949-E003
• First Posted: Jan 11, 2021
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 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
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Alcon Research: Vision; Contact lenses
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited at 3 investigative sites located in the United States.
Pre-assignment Detail	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	LID021201
Arm/Group Description	LID021201 contact lenses worn in both eyes for 7 days. Lenses were removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.
Period Title: Overall Study
STARTED	39
COMPLETED	38
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	LID021201
Arm/Group Description	LID021201 contact lenses worn in both eyes for 7 days. Lenses were removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.
Overall Participants	39
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.1 (7.0)
Sex: Female, Male (Count of Participants)
Female	29 74.4%
Male	10 25.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 7.7%
Not Hispanic or Latino	36 92.3%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 7.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 2.6%
White	35 89.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	39 100%

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, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, 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 1 Follow-up

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	LID021201
Arm/Group Description	LID021201 contact lenses worn in both eyes for 7 days. Lenses were removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution.
Measure Participants	39
Measure eyes	78
Dispense, Grade 0	78
Dispense, Grade 1	0
Dispense, Grade 2	0
Dispense, Grade 3	0
Dispense, Grade 4	0
Week 1 Follow-up, Grade 0	56
Week 1 Follow-up, Grade 1	19
Week 1 Follow-up, Grade 2	1
Week 1 Follow-up, Grade 3	0
Week 1 Follow-up, Grade 4	0

Adverse Events

Time Frame	Adverse events (AE's) were collected from time of consent to study exit, approximately 1 week.
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		LID021201 Ocular		LID021201 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		LID021201 Ocular		LID021201 Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/78 (0%)		0/39 (0%)
Serious Adverse Events
	Pretreatment		LID021201 Ocular		LID021201 Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/78 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Pretreatment		LID021201 Ocular		LID021201 Nonocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/78 (0%)		0/39 (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.