Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03417557
• Collaborator: (none)

Study Details

Study Description

Brief Summary

This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: Comfilcon A lens (test); Device: Omafilcon B lens (control)	N/A

Detailed Description

This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses
• Actual Study Start Date: Jan 12, 2018
• Actual Primary Completion Date: Apr 3, 2018
• Actual Study Completion Date: Apr 3, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Comfilcon A lens (test) Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study.	Device: Comfilcon A lens (test); contact lens; Other Names: Biofinity multifocal toric Lens (test)
Active Comparator: Omafilcon B Lens (control) Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study.	Device: Omafilcon B lens (control); contact lens; Other Names: Proclear multifocal toric lens (control)

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [up to 3 hours]

   Visual acuity is assessed for test and control lens on a logMAR chart

Secondary Outcome Measures

1. Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity [up to 3 hours]

   Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.

2. Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity [up to 3 hours]

   Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.

3. Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity [up to 3 hours]

   Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• 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 between ages 40-75 years, inclusive 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 able to participate in Parts A and B related to this work.

• Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive).

• Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).

• Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.

• Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.

• Currently wears soft contact lenses.

• Has clear corneas and no active ocular disease.

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

Exclusion Criteria:

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

• Has never worn contact lenses before.

• Has any systemic disease affecting ocular health.

• Is using any systemic or topical medications that will affect ocular health.

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

• 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 participating in any other type of eye related clinical or research study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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 - Feb 9, 2018

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03417557
• Other Study ID Numbers: CV-18-10
• First Posted: Jan 31, 2018
• Last Update Posted: May 4, 2020
• Last Verified: Apr 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: Presbyopia

Study Results

Participant Flow

Pre-assignment Detail	Three subjects did not meet the inclusion criteria. Seventeen (17) subjects completed all visits and were included in the analysis.

Arm/Group Title	Comfilcon A Lens Then Omafilcon B Lens	Omafilcon B Lens Then Comfilcon A
Arm/Group Description	Subjects are randomized to wear comfilcon A lens for up to 3 hours then omafilcon B lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lens	Subjects are randomized to wear omafilcon B lens for up to 3 hours then comfilcon A lens up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens
Period Title: 1st Intervention (3 Hours)
STARTED	8	9
COMPLETED	8	9
NOT COMPLETED	0	0
Period Title: 1st Intervention (3 Hours)
STARTED	9	8
COMPLETED	9	8
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Comfilcon A Lens (Test) and Omafilcon B (Control)
Arm/Group Description	Subjects were randomized to wear the comfilcon A (test) or omafilcon B (control) lens for up to 3 hours, either as first or second lens during this cross over study.
Overall Participants	17
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54 (7)
Sex: Female, Male (Count of Participants)
Female	11 64.7%
Male	6 35.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	17 100%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Description	Visual acuity is assessed for test and control lens on a logMAR chart
Time Frame	up to 3 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Lens (Test)	Omafilcon B Lens (Control)
Arm/Group Description	Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lens	Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens
Measure Participants	17	17
Distance: Binocular	-0.01 (0.09)	-0.03 (0.16)
Distance: Monocular (dominate eye)	-0.05 (0.12)	0.06 (0.21)
Distant: Monocular (non-dominate eye)	0.02 (0.13)	0.13 (0.22)
Near: Binocular	0.05 (0.09)	0.03 (0.07)
Near: Monocular (dominate eye)	0.14 (0.11)	0.17 (0.13)
Near: Monocular (non-dominate eye)	0.10 (0.13)	0.04 (0.18)

2. Secondary Outcome

Title	Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity
Description	Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Time Frame	up to 3 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Lens (Test)	Omafilcon B Lens (Control)
Arm/Group Description	Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lens	Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens
Measure Participants	17	17
Mean (Standard Deviation) [units on a scale]	91 (8)	79 (24)

3. Secondary Outcome

Title	Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity
Description	Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Time Frame	up to 3 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Lens (Test)	Omafilcon B Lens (Control)
Arm/Group Description	Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lens	Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens
Measure Participants	17	17
Mean (Standard Deviation) [units on a scale]	87 (12)	82 (17)

4. Secondary Outcome

Title	Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity
Description	Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.
Time Frame	up to 3 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A Lens (Test)	Omafilcon B Lens (Control)
Arm/Group Description	Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lens	Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens
Measure Participants	17	17
Mean (Standard Deviation) [units on a scale]	84 (17)	79 (26)

Adverse Events

Time Frame	Up to 3 hours per intervention.
Arm/Group Title	Comfilcon A Lens (Test)		Omafilcon B Lens (Control)
Arm/Group Description	Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study. Comfilcon A lens (test): contact lens		Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study. Omafilcon B lens (control): contact lens
All Cause Mortality
	Comfilcon A Lens (Test)		Omafilcon B Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)
Serious Adverse Events
	Comfilcon A Lens (Test)		Omafilcon B Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Comfilcon A Lens (Test)		Omafilcon B Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.