Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04492397
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 6
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

The objective of the study is to evaluate and compare the performance of study test lens to study control lens, when worn on a daily disposable modality over a period of approximately one week each

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

Detailed Description

The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates the study test lens and control lens.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
• Actual Study Start Date: Sep 30, 2020
• Actual Primary Completion Date: Mar 31, 2021
• Actual Study Completion Date: Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Contact lens Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.	Device: Test Contact Lens; Subjects will be randomized to wear test lenses.; Other Names: stenfilcon A ; Device: Control Contact Lens; Subjects will be randomized to wear control lenses.; Other Names: verofilcon A
Active Comparator: Control Contact Lens Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.	Device: Test Contact Lens; Subjects will be randomized to wear test lenses.; Other Names: stenfilcon A ; Device: Control Contact Lens; Subjects will be randomized to wear control lenses.; Other Names: verofilcon A

Outcome Measures

Primary Outcome Measures

1. Overall Lens Fit Acceptance [1 week]

   Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)

Secondary Outcome Measures

1. Lens Centration [Baseline]

   Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus")

2. Lens Centration [1 week]

   Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus")

3. Post-blink Movement [Baseline]

   Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps

4. Post-blink Movement [1 week]

   Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps

5. Push-up Tightness [Baseline]

   Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)

6. Push-up Tightness [1 week]

   Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

2. Has read and signed an information consent letter;

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

4. Habitually wears soft contact lenses in daily wear, for minimum of 6-months;

5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;

6. Has an astigmatism of ≤ 1.00 D in subjective refraction;

7. Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;

8. Demonstrates an acceptable fit with the study lenses;

9. Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;

2. Has any known active* ocular disease and/or infection;

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

6. Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;

7. Is aphakic;

8. Has undergone refractive error surgery;

9. Is an employee of the Centre for Ocular Research & Education;

10. Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or BASSET (EXMKTG-113) Study;

11. Has participated in any clinical trials within a week prior to the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Waterloo	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Lyndon Jones, PhD FCOptom, University of Waterloo

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 20, 2020

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT04492397
• Other Study ID Numbers: EX-MKTG-114
• First Posted: Jul 30, 2020
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• 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	Forty-one subjects were screened and 35 subjects started and completed the study.

Arm/Group Title	Test Contact Lens the Control Contact Lens	Control Contact Lens Then Test Contact Lens
Arm/Group Description	Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Test Contact Lens: Subjects will be randomized to wear test lenses. Control Contact Lens: Subjects will be randomized to wear control lenses.	Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Test Contact Lens: Subjects will be randomized to wear test lenses. Control Contact Lens: Subjects will be randomized to wear control lenses.
Period Title: First Intervention
STARTED	17	18
COMPLETED	17	18
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	17	18
COMPLETED	17	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Subjects will be randomized to wear control lenses and test lenses for one week. Contact lenses: Test Contact Lens Contact lenses: Control Contact Lens
Overall Participants	41
Age (Count of Participants)
<=18 years	2 4.9%
Between 18 and 65 years	39 95.1%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.8 (9.3)
Sex: Female, Male (Count of Participants)
Female	31 75.6%
Male	10 24.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Canada	41 100%

Outcome Measures

1. Primary Outcome

Title	Overall Lens Fit Acceptance
Description	Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Contact Lens	Control Contact Lens
Arm/Group Description	Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Measure Participants	35	35
Mean (Standard Deviation) [units on a scale]	3.71 (0.33)	3.73 (0.35)

2. Secondary Outcome

Title	Lens Centration
Description	Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus")
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Contact Lens	Control Contact Lens
Arm/Group Description	Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Measure Participants	35	35
Mean (Standard Deviation) [units on a scale]	0.40 (0.50)	0.29 (0.52)

3. Secondary Outcome

Title	Lens Centration
Description	Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus")
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Contact Lens	Control Contact Lens
Arm/Group Description	Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Measure Participants	35	35
Mean (Standard Deviation) [units on a scale]	0.17 (0.38)	0.20 (0.47)

4. Secondary Outcome

Title	Post-blink Movement
Description	Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Contact Lens	Control Contact Lens
Arm/Group Description	Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Measure Participants	35	35
Mean (Standard Deviation) [mm]	0.20 (0.06)	0.23 (0.06)

5. Secondary Outcome

Title	Post-blink Movement
Description	Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Contact Lens	Control Contact Lens
Arm/Group Description	Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Measure Participants	35	35
Mean (Standard Deviation) [mm]	0.20 (0.05)	0.23 (0.07)

6. Secondary Outcome

Title	Push-up Tightness
Description	Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (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 Contact Lens	Control Contact Lens
Arm/Group Description	Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Measure Participants	35	35
Mean (Standard Deviation) [units on a scale]	51 (5)	49 (6)

7. Secondary Outcome

Title	Push-up Tightness
Description	Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Contact Lens	Control Contact Lens
Arm/Group Description	Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Contact lenses: Test Contact Lens	Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Contact lenses: Control Contact Lens
Measure Participants	35	35
Mean (Standard Deviation) [units on a scale]	50 (4)	48 (4)

Adverse Events

Time Frame	From dispense up to 1 week for a total of 2 weeks
Arm/Group Title	Test Contact Lens		Control Contact Lens
Arm/Group Description	Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week.		Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week.
All Cause Mortality
	Test Contact Lens		Control Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)
Serious Adverse Events
	Test Contact Lens		Control Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Test Contact Lens		Control Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (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.