Comparing the Performance of 1 Day Multifocal Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04449263
• Collaborator: (none)
• Enrollment: 60
• Locations: 5
• Arms: 3
• Actual Duration (Months): 5.1
• Patients Per Site: 12
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: Lens A; Device: Lens B; Device: Habitual Lenses	N/A

Detailed Description

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted at up to 5 clinical practice sites in the United States. Subjects were dispensed their habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens type will be worn for 2 weeks after randomization.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparing the Performance of 1 Day Multifocal Contact Lenses
• Actual Study Start Date: Jul 27, 2020
• Actual Primary Completion Date: Dec 7, 2020
• Actual Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lens A (Test) Subjects will be randomized to wear Lens A (test) the control Lens B for 2 weeks in this randomized, cross-over bilateral dispensing study.	Device: Lens A; Subjects will be randomized to wear Lens A (test) for 2 weeks.; Other Names: FDA Approved, non-marketed, daily disposable multifocal lens ; Device: Lens B; Subjects will be randomized to wear Lens B (control) for 2 weeks.; Other Names: FDA Approved, daily disposable multifocal lens ; Device: Habitual Lenses; All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.
Active Comparator: Lens B (Control) Subjects will be randomized to wear Lens B (control) and Lens A (Test) for 2 weeks in this randomized, cross-over bilateral dispensing study.	Device: Lens A; Subjects will be randomized to wear Lens A (test) for 2 weeks.; Other Names: FDA Approved, non-marketed, daily disposable multifocal lens ; Device: Lens B; Subjects will be randomized to wear Lens B (control) for 2 weeks.; Other Names: FDA Approved, daily disposable multifocal lens ; Device: Habitual Lenses; All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.
Active Comparator: Habitual Lenses All subjects will wear their habitual lenses for two weeks prior to randomization of Test lens A and control lens B.	Device: Habitual Lenses; All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.

Outcome Measures

Primary Outcome Measures

1. Subjective At-home Ratings for Ease of Lens Handling for Insertion [Day 13]

   Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 42 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Is at least 42 years of age and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Self reports having a full eye examination in the previous two years;

4. Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;

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

6. Habitually wears multifocal soft contact lenses, for the past 3 months minimum;

7. Has refractive astigmatism no higher than -0.75DC;

8. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;

9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (sphere +4 to -6; near addition or LOW, MEDIUM, HIGH).

Exclusion Criteria:

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

2. Habitually wears one of the study contact lenses;

3. Has any known active* ocular disease and/or infection that contraindicates contact lens wear;

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

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

6. Has known sensitivity to the diagnostic sodium fluorescein used in the study;

7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;

8. Has undergone refractive error surgery or intraocular surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Poway Eyecare	San Diego	California	United States	92131
2	Golden Optometric Group	Whittier	California	United States	90606
3	Golden Vision	Sarasota	Florida	United States	34237
4	Kannarr Eye Care	Pittsburg	Kansas	United States	66762
5	ProCare Vision Center	Granville	Ohio	United States	43023

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Wayne Golden, Golden Vision
• Principal Investigator: Keith Wan, Scripps Poway Eyecare
• Principal Investigator: Shane Kannarr, Kannarr Eye Care
• Principal Investigator: David Ardaya, Golden Optometric Group
• Principal Investigator: Katherine Bickle, ProCare Vision Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 5, 2020

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT04449263
• Other Study ID Numbers: EX-MKTG-109
• First Posted: Jun 26, 2020
• Last Update Posted: Jun 22, 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: Presbyopia

Study Results

Participant Flow

Recruitment Details	60 subjects were enrolled and 1 subject discontinued because of screen failure prior to dispense of their habitual lenses.
Pre-assignment Detail	All 59 subjects wore their habitual lenses for two weeks prior to randomization to test lens and control lens.

Arm/Group Title	Lens A (Test) Then Lens B (Control)	Lens B (Control) Then Lens A (Test)
Arm/Group Description	Subjects wore their habitual lenses for 2 weeks and were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study. Contact lens: Habitual Lenses Contact Lens: Test Lens A Contact Lens: Control Lens B	All Subjects wore their habitual lenses for 2 weeks prior to randomization and were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study. Contact Lens: Habitual lenses Contact lens: Control Lens B Contact Lens : Test lens A
Period Title: First Intervention
STARTED	29	30
COMPLETED	29	30
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	29	30
COMPLETED	29	30
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	29	30
COMPLETED	29	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Subjects wore their habitual lenses for two weeks and then randomized to wear Test lens A and Control Lens B for 2 weeks.
Overall Participants	59
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	56 94.9%
>=65 years	3 5.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.5 (7.3)
Sex: Female, Male (Count of Participants)
Female	50 84.7%
Male	9 15.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	59 100%

Outcome Measures

1. Primary Outcome

Title	Subjective At-home Ratings for Ease of Lens Handling for Insertion
Description	Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy)
Time Frame	Day 13

Outcome Measure Data

Analysis Population Description

One subject was not included in the analysis for all study arms because of protocol deviation. One more subject was excluded form the analysis from Len B control Arm only.

Arm/Group Title	Subjects Habitual Lenses	Lens A (Test)	Lens B (Control)
Arm/Group Description	Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens. Contact Lenses: Habitual Lenses	Subjects were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study. Contact Lens: Test Lens A	Subjects were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study. Contact lens: Control Lens B
Measure Participants	58	58	57
Mean (Standard Deviation) [units on a scale]	8.90 (1.59)	8.28 (2.10)	9.18 (1.12)

Adverse Events

Time Frame	All subjects wore their habitual lenses for two weeks and then randomized to wear test lens A and control lens B for 2 weeks, a total of 6 weeks.
Arm/Group Title	Subjects Habitual Lenses		Lens A (Test)		Lens B (Control)
Arm/Group Description	All Subjects wore their habitual lenses for 2 weeks prior to randomization of test lens and control lens. Contact Lenses: Habitual Lenses		Subjects were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study. Contact Lens: Test Lens A		Subjects were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study. Contact lens: Control Lens B
All Cause Mortality
	Subjects Habitual Lenses		Lens A (Test)		Lens B (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/59 (0%)		0/59 (0%)
Serious Adverse Events
	Subjects Habitual Lenses		Lens A (Test)		Lens B (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/59 (0%)		0/59 (0%)
Other (Not Including Serious) Adverse Events
	Subjects Habitual Lenses		Lens A (Test)		Lens B (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/59 (0%)		0/59 (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.