Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03372551
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.8
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: somofilcon A 1 day test lens; Device: somofilcon A 1 day control lens	N/A

Detailed Description

The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing studyThis will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study
• Masking: Double (Participant, Investigator)
• Masking Description: Both the participants and study investigators will be masked to the randomization schedule of the contact lenses used.
• Primary Purpose: Treatment
• Official Title: Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses
• Actual Study Start Date: Nov 29, 2017
• Actual Primary Completion Date: Dec 22, 2017
• Actual Study Completion Date: Apr 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: somofilcon A 1 day test lens Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.	Device: somofilcon A 1 day test lens; Contact lens; Other Names: somofilcon A daily disposable test soft contact lens Invigor I Test lens ; Device: somofilcon A 1 day control lens; Contact lens; Other Names: somofilcon A daily disposable control soft contact lens Select 1-Day Control lens
Active Comparator: somofilcon A 1 day control lens Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.	Device: somofilcon A 1 day test lens; Contact lens; Other Names: somofilcon A daily disposable test soft contact lens Invigor I Test lens ; Device: somofilcon A 1 day control lens; Contact lens; Other Names: somofilcon A daily disposable control soft contact lens Select 1-Day Control lens

Outcome Measures

Primary Outcome Measures

1. Comfort [up to 1 week]

   Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)

2. Preference [up to 1 week]

   Overall lens that subject prefers or no preference

3. Vision [Up to 1 week]

   Visual acuity measured in logMAR

4. Subjective Vision [up to 1 week]

   Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)

5. Corneal Staining [up to 1 week]

   Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps

6. Conjunctival Staining [up to 1 week]

   Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Is at least 17 years of age and has full legal capacity to volunteer;

• Has had a self-reported oculo-visual examination in the last two years;

• Has read, understood, and signed the information consent letter;

• Is willing and able to follow instructions and maintain the appointment schedule;

• Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);

• Must be able to achieve 20/30 or better (in each eye) with the study lenses;

• Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;

• Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);

• Has no more than 0.75 diopters of refractive astigmatism;

• Has clear corneas and no active* ocular disease;

• Has not worn lenses for at least 12 hours before the examination.

Exclusion Criteria:

• Is presently participating in any other clinical or research study including eye related clinical or research study;

• Has never worn contact lenses before.

• Has any systemic disease affecting ocular health.

• Has any active* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.

• Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.

• Has any known sensitivity to fluorescein dye or products to be used in the study.

• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.

• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.

• Is aphakic.

• Has undergone corneal refractive surgery.

• Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 20, 2017

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03372551
• Other Study ID Numbers: CV-16-43
• First Posted: Dec 13, 2017
• Last Update Posted: Jul 23, 2019
• Last Verified: Jul 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.: Yes
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	Three (3) subjects did not meet inclusion criteria and were excluded from the analysis. One subject was enrolled and later discontinued.

Arm/Group Title	Somofilcon A 1 Day Test Lens First, Then Control 1 Day Lens	Somofilcon A 1 Day Control Lens First, Then 1 Day Test Lens
Arm/Group Description	Subjects wear the somofilcon A 1 day Test Lens first for one week, then somofilcon A 1 day Control lens for one week. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Subjects wear the somofilcon A 1 day Control lens first for one week, then somofilcon A 1 day Test lens for one week. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
Period Title: First Intervention (1 Week)
STARTED	17	16
COMPLETED	16	16
NOT COMPLETED	1	0
Period Title: First Intervention (1 Week)
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Somofilcon A 1 Day Test vs Control Contact Lens
Arm/Group Description	Each subjects randomized to wear either the test or control as a matched pair and cross over to second matched pair. somofilcon A 1 day test lens: Test / Contact lens somofilcon A 1 day control lens: Test / Contact lens
Overall Participants	32
Age (Count of Participants)
<=18 years	1 3.1%
Between 18 and 65 years	31 96.9%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26 (9)
Sex: Female, Male (Count of Participants)
Female	29 90.6%
Male	3 9.4%
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	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	32 100%
Region of Enrollment (participants) [Number]
Canada	32 100%

Outcome Measures

1. Primary Outcome

Title	Comfort
Description	Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)
Time Frame	up to 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A 1 Day Test Lens	Somofilcon A 1 Day Control Lens
Arm/Group Description	Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
Measure Participants	32	32
Comfort at Dispense	90 (8)	89 (11)
Comfort at Insertion after 1 week	86 (11)	87 (16)
Comfort during day after 1 week	84 (11)	86 (11)
Comfort end day after 1 week	75 (15)	78 (16)
Overall comfort after 1 week of lens wear	82 (11)	85 (12)

2. Primary Outcome

Title	Preference
Description	Overall lens that subject prefers or no preference
Time Frame	up to 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon A 1 Day Test / Control Contact Lens
Arm/Group Description	Each subjects randomized to wear either the somofilcon A 1 day test or somofilcon A 1 day control as a matched pair and cross over to second matched pair. somofilcon A 1 day test lens: Test / Contact lens somofilcon A 1 day control lens: Test / Contact lens
Measure Participants	32
Strongly preferred somofilcon A 1 Day Test lens	5 15.6%
Slightly preferred somofilcon A 1 Day Test lens	9 28.1%
No preference	1 3.1%
Slightly preferred somofilcon A 1 Day Control lens	5 15.6%
Strongly preferred somofilcon A 1 Day control lens	12 37.5%

3. Primary Outcome

Title	Vision
Description	Visual acuity measured in logMAR
Time Frame	Up to 1 week

Outcome Measure Data

Analysis Population Description

Dispensing - n=32 participants total, 1 week = 31 participants total due to a nonserious adverse events for somofilcon A 1 day test lens.

Arm/Group Title	Somofilcon A 1 Day Test Lens Dispense	Somofilcon A 1 Day Test Lens 1 Week	Somofilcon A 1 Day Control Lens Dispense	Somofilcon A 1 Day Control Lens 1 Week
Arm/Group Description	Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
Measure Participants	32	31	32	31
High Illumination high contrast monocular	-0.10 (0.07)	-0.10 (0.07)	-0.11 (0.07)	-0.11 (0.06)
High Illumination high contrast binocular	-0.15 (0.06)	-0.15 (0.07)	-0.15 (0.06)	-0.16 (0.06)
Low Illumination high contrast monocular	-0.08 (0.05)	-0.07 (0.07)	-0.09 (0.07)	-0.10 (0.06)
Low Illumination high contrast binocular	-0.13 (0.06)	-0.13 (0.07)	-0.13 (0.06)	-0.14 (0.05)

4. Primary Outcome

Title	Subjective Vision
Description	Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)
Time Frame	up to 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Somofilcon 1 Day Test Lens: Vision Quality/Clarity During Day	Somofilcon A Control Lens: Vision Quality/Clarity During Day
Arm/Group Description	Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
Measure Participants	32	32
Dispense	92 (9)	92 (6)
1 week	88 (12)	91 (11)

5. Primary Outcome

Title	Corneal Staining
Description	Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps
Time Frame	up to 1 week

Outcome Measure Data

Analysis Population Description

Baseline n=32 participants / 64 eyes, 1 week n = 31 participants / 62 eyes due to non-serious adverse event participant's measurements weren't completed.

Arm/Group Title	Somofilcon A 1 Day Test Lens	Somofilcon A 1 Day Control Lens
Arm/Group Description	Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
Measure Participants	32	32
Measure Eye	64	64
Baseline	0.16 (0.25)	0.16 (0.25)
1 week	0.20 (0.26)	0.18 (0.42)

6. Primary Outcome

Title	Conjunctival Staining
Description	Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps
Time Frame	up to 1 week

Outcome Measure Data

Analysis Population Description

Baseline n=32 participants / 64 eyes, 1 week n= 31 participants / 62 eyes due to non-serious adverse event participant's measurements weren't completed.

Arm/Group Title	Somofilcon A 1 Day Test Lens	Somofilcon A 1 Day Control Lens
Arm/Group Description	Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens	Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
Measure Participants	32	32
Measure Eyes	64	64
Baseline	0.20 (0.25)	0.20 (0.25)
1 week	0.72 (0.57)	0.91 (0.71)

Adverse Events

Time Frame	From dispense to completion of follow up, up to 2 weeks.
Arm/Group Title	Somofilcon A 1 Day Test Lens		Somofilcon A 1 Day Control Lens
Arm/Group Description	Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens		Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair. somofilcon A 1 day test lens: Contact lens somofilcon A 1 day control lens: Contact lens
All Cause Mortality
	Somofilcon A 1 Day Test Lens		Somofilcon A 1 Day Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)
Serious Adverse Events
	Somofilcon A 1 Day Test Lens		Somofilcon A 1 Day Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Somofilcon A 1 Day Test Lens		Somofilcon A 1 Day Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.