Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03095027
• Collaborator: (none)
• Enrollment: 54
• Locations: 3
• Arms: 2
• Actual Duration (Days): 26
• Patients Per Site: 18
• Patients Per Site Per Month: 21.1

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: FID122819 contact lenses; Device: Stenfilcon A contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Alcon Observer and Sponsor personnel were also masked.
• Primary Purpose: Treatment
• Official Title: Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear
• Actual Study Start Date: Apr 19, 2017
• Actual Primary Completion Date: May 15, 2017
• Actual Study Completion Date: May 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: FID122819, then stenfilcon A FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week	Device: FID122819 contact lenses; Investigational spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: DDT2 Verofilcon A ; Device: Stenfilcon A contact lenses; Commercially available spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: MyDay®
Other: Stenfilcon A, then FID122819 Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week	Device: FID122819 contact lenses; Investigational spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: DDT2 Verofilcon A ; Device: Stenfilcon A contact lenses; Commercially available spherical silicone hydrogel contact lenses for daily disposable wear; Other Names: MyDay®

Outcome Measures

Primary Outcome Measures

1. Visual Acuity (VA) [Baseline/Dispense (Day 1), Week 1, each product]

   VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.

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 IRB-approved Informed Consent Form;

• Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:

• Manifest cylinder of ≤ 0.75 diopter (D) in each eye;

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

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;

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

• Ocular or intraocular surgery within the previous 12 months or planned during the study;

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

• Any previous or current wear of MYDAY;

• Habitually wearing monovision or multifocal lenses during the last 3 months;

• 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 and artificial tear or rewetting drops that would require instillation during contact lens wear;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Longwood	Florida	United States	32779
2	Alcon Investigative Site	Maitland	Florida	United States	32751
3	Alcon Investigative Site	Johns Creek	Georgia	United States	30097

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Sr. Clinical Manager, Trial Management Operations, Alcon, A Novartis Division

Study Documents (Full-Text)

• Study Protocol - Mar 7, 2017
• Statistical Analysis Plan - Mar 21, 2017

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT03095027
• Other Study ID Numbers: CLE383-C003
• First Posted: Mar 29, 2017
• Last Update Posted: Feb 4, 2019
• Last Verified: Jan 1, 2019

• 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 lens, silicone hydrogel, daily disposable, visual acuity
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 3 study centers located in the United States.
Pre-assignment Detail	Of the 54 enrolled, 3 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (51).

Arm/Group Title	FID122819, Then Stenfilcon A	Stenfilcon A, Then FID122819
Arm/Group Description	FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week.	Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week.
Period Title: Period 1, First Week of Wear
STARTED	27	24
COMPLETED	27	24
NOT COMPLETED	0	0
Period Title: Period 1, First Week of Wear
STARTED	27	24
COMPLETED	26	24
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	FID122819 and stenfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Overall Participants	51
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.5 (9.8)
Sex: Female, Male (Count of Participants)
Female	38 74.5%
Male	13 25.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 3.9%
Not Hispanic or Latino	49 96.1%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity (VA)
Description	VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.
Time Frame	Baseline/Dispense (Day 1), Week 1, each product

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	FID112819	Stenfilcon A
Arm/Group Description	FID122819 contact lenses worn during Period 1 or Period 2 for 1 week	Stenfilcon A contact lenses worn during Period 1 or Period 2 for 1 week
Measure Participants	51	51
Measure Eyes	102	102
Dispense	-0.08 (0.06)	-0.09 (0.06)
Week 1	-0.09 (0.06)	-0.09 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FID112819, Stenfilcon A
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The pre-specified non-inferiority margin is 0.05. With a sample size of 10, there was approximately 80% power to reject the null hypothesis of inferiority in visual acuity with assumed standard deviation of 0.0474 (one-sided alpha=0.05)
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LSM Difference
	Estimated Value	0.00
	Confidence Interval	(1-Sided) 95%; to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.00
	Estimation Comments

Adverse Events

Time Frame	Dispense through study completion, an average of 2 weeks
Adverse Event Reporting Description	Adverse Events (AEs) were 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 includes all subjects/eyes exposed to any study lens evaluated (Safety Analysis Set), based on treatment-specific exposure.
Arm/Group Title	FID122819		Stenfilcon A
Arm/Group Description	Subjects exposed to FID122819 contact lenses during Period 1 or Period 2		Subjects exposed to stenfilcon A contact lenses during Period 1 or Period 2
All Cause Mortality
	FID122819		Stenfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)
Serious Adverse Events
	FID122819		Stenfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	FID122819		Stenfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/51 (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.