Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03586167
• Collaborator: (none)
• Enrollment: 88
• Locations: 4
• Arms: 2
• Actual Duration (Months): 1.9
• Patients Per Site: 22
• Patients Per Site Per Month: 11.7

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily wear.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors	Device: LID014341 contact lenses; Device: Comfilcon A contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens
• Actual Study Start Date: Aug 1, 2018
• Actual Primary Completion Date: Sep 27, 2018
• Actual Study Completion Date: Sep 27, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LID014341 LID014341 contact lenses worn bilaterally (in both eyes) for 30 days on a daily wear basis	Device: LID014341 contact lenses; Investigational monthly replacement silicone hydrogel contact lenses with water gradient coating
Active Comparator: Biofinity Comfilcon A contact lenses worn bilaterally for 30 days on a daily wear basis	Device: Comfilcon A contact lenses; Silicone hydrogel contact lenses; Other Names: BIOFINITY©

Outcome Measures

Primary Outcome Measures

1. Distance Visual Acuity (VA) [Day 30]

   VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical 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:

• Able to understand and sign an informed consent form approved by an Institutional review board (IRB);

• Successful wear of spherical monthly 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;

• Best-corrected visual acuity (BCVA) 20/25 or better in each eye;

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

Exclusion Criteria:

• Any conditions or use of medications that could contraindicate contact lens wear;

• History of or plan to have refractive surgery in either eye;

• Irregular cornea in either eye;

• Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;

• Current or history of intolerance, hypersensitivity or allergy to any component of the study products;

• 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;

• Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;

• Habitual Biofinity contact lens wearers.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Maitland	Florida	United States	32751
2	Alcon Investigative Site	Johns Creek	Georgia	United States	30097
3	Alcon Investigative Site	Bloomington	Illinois	United States	61701
4	Alcon Investigative Site	Memphis	Tennessee	United States	38111

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Alcon Research, Alcon Research

Study Documents (Full-Text)

• Study Protocol - Jun 18, 2018
• Statistical Analysis Plan - Jul 13, 2018

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT03586167
• Other Study ID Numbers: CLY935-C004
• First Posted: Jul 13, 2018
• Last Update Posted: Jun 30, 2021
• Last Verified: Jun 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
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 4 study centers located in the US.
Pre-assignment Detail	Of the 88 enrolled, 2 subjects exited as screen failures prior to randomization. This reporting group includes all randomized subjects (86).

Arm/Group Title	LID014341	Biofinity
Arm/Group Description	LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis	Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis
Period Title: Overall Study
STARTED	58	28
COMPLETED	57	28
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	LID014341	Biofinity	Total
Arm/Group Description	LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis	Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis	Total of all reporting groups
Overall Participants	58	28	86
Overall Eyes	116	56	172
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.0 (11.6)	40.7 (12.9)	39.6 (12.0)
Sex: Female, Male (Count of Participants)
Female	38 65.5%	20 71.4%	58 67.4%
Male	20 34.5%	8 28.6%	28 32.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1.7%	2 7.1%	3 3.5%
Not Hispanic or Latino	56 96.6%	26 92.9%	82 95.3%
Unknown or Not Reported	1 1.7%	0 0%	1 1.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 3.4%	0 0%	2 2.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 6.9%	3 10.7%	7 8.1%
White	52 89.7%	25 89.3%	77 89.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Distance Visual Acuity (VA)
Description	VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

Safety Analysis Set. Overall number of units analyzed is the number of eyes with non-missing response.

Arm/Group Title	LID014341	Biofinity
Arm/Group Description	LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis	Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis
Measure Participants	57	28
Measure Eyes	114	56
Mean (Standard Deviation) [logMAR]	-0.09 (0.07)	-0.09 (0.07)

Adverse Events

Time Frame	Dispense through study completion, an average of 1 month (30 days)
Adverse Event Reporting Description	Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population included all subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set), based on treatment-specific exposure.
Arm/Group Title	LID014341		Biofinity
Arm/Group Description	LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis		Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis
All Cause Mortality
	LID014341		Biofinity
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/28 (0%)
Serious Adverse Events
	LID014341		Biofinity
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	LID014341		Biofinity
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/28 (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.