A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03951610
• Collaborator: (none)
• Enrollment: 52
• Locations: 2
• Arms: 2
• Actual Duration (Months): 3.4
• Patients Per Site: 26
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.

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

Detailed Description

The purpose of this study is to evaluate the clinical performance of a silicone-hydrogel test contact lens compared to the commercially available silicone-hydrogel (control) contact lens when worn over one week for each lens type in a randomized, bilateral, cross-over, dispensing study on a daily disposable basis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 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: Double (participant and investigator)
• Primary Purpose: Treatment
• Official Title: A Dispensing Clinical Trial of Invigor 1 Daily Disposable Lens Against Clariti 1-day Lens
• Actual Study Start Date: Feb 21, 2019
• Actual Primary Completion Date: Apr 5, 2019
• Actual Study Completion Date: Jun 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test lens Subjects wearing the test lens for one week, either randomized as the first or second pair.	Device: Test lens; contact lens; Other Names: Invigor I DD lens Somofilcon A 1 day Test ; Device: Control lens; contact lens; Other Names: Clariti 1-day Somofilcon A 1 day control
Active Comparator: Control lens Subjects wearing the control lens for one week, either randomized as the first or second pair.	Device: Test lens; contact lens; Other Names: Invigor I DD lens Somofilcon A 1 day Test ; Device: Control lens; contact lens; Other Names: Clariti 1-day Somofilcon A 1 day control

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Lens Centration [Baseline]

   Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)

2. Number of Participants With Lens Centration [1 week]

   Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)

3. Post Blink Movement [Baseline]

   Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)

4. Post Blink Movement [1 week]

   Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)

5. Primary Gaze Lag [baseline]

   Primary Gaze Lag (measured in mm at 0.1mm steps)

6. Primary Gaze Lag [1 week]

   Primary Gaze Lag (measured in mm at 0.1mm steps)

7. Up Gaze Lag [Baseline]

   Up Gaze Lag (measured in mm at 0.1mm steps)

8. Up Gaze Lag [1 week]

   Up Gaze Lag (measured in mm at 0.1mm steps)

9. Push-Up Tightness [baseline]

   Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)

10. Push-Up Tightness [1 week]

    Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)

11. Overall Fit Acceptance [Baseline]

    Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum

12. Overall Fit Acceptance [1 week]

    Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum

13. Number of Participants With Overall Lens Fit Impression [Baseline]

    Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable

14. Number of Participants With Overall Lens Fit Impression [1 week]

    Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable

Secondary Outcome Measures

1. Subjective Comfort Rating [Baseline]

   Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)

2. Subjective Comfort Rating [1-week]

   Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• Is at least 18 years of age and has full legal capacity to volunteer.

• Has read and understood the information consent letter.

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

• Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.

• Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops

• Requires spectacle lens spherical powers between -1.00 to -5.75 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.

• Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit

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 enrollment (by verbal confirmation at the screening visit).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Eye Center at Ketchum Health	Anaheim	California	United States	92807
2	Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University	Bloomington	Indiana	United States	47405

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 17, 2018

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03951610
• Other Study ID Numbers: CV-19-01
• First Posted: May 15, 2019
• Last Update Posted: Jun 18, 2020
• Last Verified: May 1, 2020

• 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: Myopia

Study Results

Participant Flow

Arm/Group Title	Test Lens Then Control Lens	Control Lens Then Test Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week then the control lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week then the test lens for one week. Control lens: contact lens
Period Title: First Intervention
STARTED	27	25
COMPLETED	27	25
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	27	25
COMPLETED	27	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Total Participants
Overall Participants	52
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	52 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27 (6)
Sex: Female, Male (Count of Participants)
Female	34 65.4%
Male	18 34.6%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	52 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Lens Centration
Description	Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Optimal	17 32.7%	12 NaN
Slightly Decentered	34 65.4%	39 NaN
Extreme Decentered	1 1.9%	1 NaN

2. Primary Outcome

Title	Number of Participants With Lens Centration
Description	Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Optimal	20 38.5%	16 NaN
Slightly Decentered	31 59.6%	36 NaN
Extreme Decentered	1 1.9%	0 NaN

3. Primary Outcome

Title	Post Blink Movement
Description	Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Mean (Standard Deviation) [millimeters (mm)]	0.25 (0.10)	0.26 (0.09)

4. Primary Outcome

Title	Post Blink Movement
Description	Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Mean (Standard Deviation) [millimeters (mm)]	0.26 (0.12)	0.25 (0.12)

5. Primary Outcome

Title	Primary Gaze Lag
Description	Primary Gaze Lag (measured in mm at 0.1mm steps)
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Mean (Standard Deviation) [millimeters (mm)]	0.22 (0.12)	0.25 (0.16)

6. Primary Outcome

Title	Primary Gaze Lag
Description	Primary Gaze Lag (measured in mm at 0.1mm steps)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Mean (Standard Deviation) [millimeters (mm)]	0.23 (0.12)	0.22 (0.15)

7. Primary Outcome

Title	Up Gaze Lag
Description	Up Gaze Lag (measured in mm at 0.1mm steps)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Mean (Standard Deviation) [millimeters (mm)]	0.28 (0.10)	0.31 (0.12)

8. Primary Outcome

Title	Up Gaze Lag
Description	Up Gaze Lag (measured in mm at 0.1mm steps)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Mean (Standard Deviation) [millimeters (mm)]	0.28 (0.12)	0.29 (0.20)

9. Primary Outcome

Title	Push-Up Tightness
Description	Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Mean (Standard Deviation) [percentage]	46 (6)	47 (4)

10. Primary Outcome

Title	Push-Up Tightness
Description	Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Mean (Standard Deviation) [percentage]	45 (6)	48 (9)

11. Primary Outcome

Title	Overall Fit Acceptance
Description	Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Mean (Standard Deviation) [units on a scale]	3.12 (0.39)	3.08 (0.36)

12. Primary Outcome

Title	Overall Fit Acceptance
Description	Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Mean (Standard Deviation) [units on a scale]	3.12 (0.41)	3.13 (0.44)

13. Primary Outcome

Title	Number of Participants With Overall Lens Fit Impression
Description	Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Reduced Unacceptable	0 0%	0 NaN
Reduced Acceptable	7 13.5%	7 NaN
Optimal	43 82.7%	44 NaN
Excessive Acceptable	2 3.8%	1 NaN
Excessive Unacceptable	0 0%	0 NaN

14. Primary Outcome

Title	Number of Participants With Overall Lens Fit Impression
Description	Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Reduced Unacceptable	0 0%	1 NaN
Reduced Acceptable	9 17.3%	9 NaN
Optimal	41 78.8%	41 NaN
Excessive Acceptable	2 3.8%	1 NaN
Excessive Unacceptable	0 0%	0 NaN

15. Secondary Outcome

Title	Subjective Comfort Rating
Description	Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Mean (Standard Deviation) [units on a scale]	9.0 (1.2)	9.4 (0.9)

16. Secondary Outcome

Title	Subjective Comfort Rating
Description	Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)
Time Frame	1-week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Lens	Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens	Subjects were randomized to wear the control lens for one week. Control lens: contact lens
Measure Participants	52	52
Mean (Standard Deviation) [units on a scale]	9.1 (1.1)	9.1 (1.0)

Adverse Events

Time Frame	From baseline up to 1 week for each intervention, a total of 2 weeks.
Arm/Group Title	Test Lens		Control Lens
Arm/Group Description	Subjects were randomized to wear the test lens for one week. Test lens: contact lens		Subjects were randomized to wear the test lens for one week. Control lens: contact lens
All Cause Mortality
	Test Lens		Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)
Serious Adverse Events
	Test Lens		Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Test Lens		Control Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (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.