Performance of Wearers of Stenfilcon A Contact Lenses After A Refit With Test Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03496701
• Collaborator: (none)
• Enrollment: 77
• Locations: 4
• Arm: 1
• Actual Duration (Months): 9
• Patients Per Site: 19.3
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Test lens; Device: control lens	N/A

Detailed Description

This study is a prospective, multi-center, open label, bilateral, daily wear, one week dispensing study comparing performance of wearers of stenfilcon A control contact lenses after refit with test contact lenses.

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Performance of Wearers of MyDay Sphere Lenses After A Refit With MyDay Energys Lenses for One Week
• Actual Study Start Date: Apr 18, 2018
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Jan 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stenfilcon A / Test lens All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week.	Device: Test lens; contact lens; Other Names: stenfilcon A Test lens ; Device: control lens; contact lens; Other Names: stenfilcon A Control lens

Outcome Measures

Primary Outcome Measures

1. Overall Lens Fit Acceptance [Baseline (After 10 minutes of lens dispense)]

   Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)

2. Overall Lens Fit Acceptance [1 week on each study lenses]

   Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)

Secondary Outcome Measures

1. Lens Centration [Baseline - After 10 minutes of lens dispense]

   Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)

2. Lens Centration [1 week on each study lenses]

   Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)

3. Post-blink Movement [Baseline (after 10 minutes of lens dispense)]

   Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)

4. Post-blink Movement [1 week on each study lenses]

   Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

• Is between 18 and 35 years of age (inclusive)

• Has read and signed the informed consent letter

• Is willing and anticipated to follow instructions and maintain the appointment schedule

• Habitually wears soft spherical contact lenses with a power between -1.00D to -6.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day.

• Habitually wears or is able to be adequately refit into MyDay Sphere lenses

• Demonstrates an acceptable fit with the study lenses

• Is correctable to a distance visual acuity of 0.20 logMAR (approximately 20/30) or better (in each eye) with the study contact lenses

• Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.

• Manifest cylindrical spectacle refraction does not exceed -0.75DC in either eye

• Has clear corneas and no active ocular disease

• Has a contact lens refraction that fits within the available parameters of the study lenses.

Exclusion Criteria:

A person will be excluded from the study if he/she:

• Is participating in any concurrent clinical research study

• Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)

• Has a systemic condition that, in the opinion of the investigator, may affect the study measures

• Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures.

• Presents with slit lamp findings or clinically significant anterior segment abnormalities that would contraindicate contact lens wear such as:

• Pathological dry eye or associated findings

• Significant pterygium, pinguecula, or corneal scars within the visual axis

• Neovascularization > 0.75 mm in from of the limbus

• Giant papillary conjunctivitis (GCP) worse than grade 1

• Anterior uveitis or iritis (or history in past year)

• Seborrheic eczema of eyelid region, Seborrheic conjunctivitis

• History of corneal ulcers or fungal infections

• Poor personal hygiene

• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

• Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study

• Has aphakia, keratoconus or a highly irregular cornea.

• Has presbyopia or has dependence on spectacles for near work over the contact lenses.

• Has undergone refractive surgery.

• Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrollment

• Has participated in any other type of eye related clinical or research study within the last 7 days

• Is habitually using rewetting/ lubricating eye drops (more than once per day)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eric White, O.D., Inc.	San Diego	California	United States	92123
2	Golden Optometric Group	Whittier	California	United States	90606
3	Golden Vision	Sarasota	Florida	United States	34232
4	Nittany Eye Associates	State College	Pennsylvania	United States	16801

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: David Ardaya, Golden Optometric Group, CA
• Principal Investigator: Shane Kannarr, Kannarr Eye Care, KS
• Principal Investigator: Michael Cymbor, Nittany Eye Associates, PA
• Principal Investigator: Wayne Golden, Golden Vision, FL
• Principal Investigator: Eric M. White, CA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 16, 2018

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03496701
• Other Study ID Numbers: EX-MKTG-86
• First Posted: Apr 12, 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.: Yes
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Overall Study
Arm/Group Description	All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week. Test lens: contact lens control lens: contact lens
Period Title: Overall Study
STARTED	77
COMPLETED	77
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week. Test lens: contact lens control lens: contact lens
Overall Participants	77
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	77 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.9 (5.1)
Sex: Female, Male (Count of Participants)
Female	57 74%
Male	20 26%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	77 100%

Outcome Measures

1. Primary Outcome

Title	Overall Lens Fit Acceptance
Description	Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)
Time Frame	Baseline (After 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Test Lens	Stenfilcon A Control Lens
Arm/Group Description	All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens	All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens
Measure Participants	77	77
Mean (Standard Deviation) [units on a scale]	3.90 (0.26)	3.81 (0.34)

2. Primary Outcome

Title	Overall Lens Fit Acceptance
Description	Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)
Time Frame	1 week on each study lenses

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Test Lens	Stenfilcon A Control Lens
Arm/Group Description	All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens	All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens
Measure Participants	77	77
Mean (Standard Deviation) [units on a scale]	3.79 (0.47)	3.83 (0.35)

3. Secondary Outcome

Title	Lens Centration
Description	Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)
Time Frame	Baseline - After 10 minutes of lens dispense

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Test Lens	Stenfilcon A Control Lens
Arm/Group Description	All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens	All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens
Measure Participants	77	77
Optimum	76 98.7%	76 NaN
Acceptable	1 1.3%	1 NaN
Unacceptable	0 0%	0 NaN

4. Secondary Outcome

Title	Lens Centration
Description	Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)
Time Frame	1 week on each study lenses

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Test Lens	Stenfilcon A Control Lens
Arm/Group Description	All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens	All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens
Measure Participants	77	77
Optimum	75 97.4%	76 NaN
Acceptable	2 2.6%	1 NaN
Unacceptable	0 0%	0 NaN

5. Secondary Outcome

Title	Post-blink Movement
Description	Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)
Time Frame	Baseline (after 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Test Lens	Stenfilcon A Control Lens
Arm/Group Description	All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens	All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens
Measure Participants	77	77
Mean (Standard Deviation) [units on a scale]	2.04 (0.34)	1.97 (0.36)

6. Secondary Outcome

Title	Post-blink Movement
Description	Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)
Time Frame	1 week on each study lenses

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Test Lens	Stenfilcon A Control Lens
Arm/Group Description	All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens	All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens
Measure Participants	77	77
Mean (Standard Deviation) [units on a scale]	1.92 (0.42)	1.96 (0.34)

Adverse Events

Time Frame	From dispense up to 1 week on each study lenses, a total of 2 weeks.
Arm/Group Title	Stenfilcon A Test Lens		Stenfilcon A Control Lens
Arm/Group Description	All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens		All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens
All Cause Mortality
	Stenfilcon A Test Lens		Stenfilcon A Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/77 (0%)
Serious Adverse Events
	Stenfilcon A Test Lens		Stenfilcon A Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/77 (0%)
Other (Not Including Serious) Adverse Events
	Stenfilcon A Test Lens		Stenfilcon A Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/77 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.