Clinical Evaluation of Investigational Multifocal Toric Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03519282
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

Condition or Disease	Intervention/Treatment	Phase
Presbyopia; Astigmatism	Device: comfilcon A multifocal toric lens; Device: omafilcon A Multifocal Toric Lens	N/A

Detailed Description

This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Biofinity Multifocal Toric Contact Lenses
• Actual Study Start Date: Apr 25, 2018
• Actual Primary Completion Date: Jul 24, 2018
• Actual Study Completion Date: Jul 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Multifocal Toric Lens comfilcon A multifocal toric lens	Device: comfilcon A multifocal toric lens; contact lens; Other Names: Test Multifocal Toric Lens Biofinity multifocal toric lens ; Device: omafilcon A Multifocal Toric Lens; contact lens; Other Names: Proclear multifocal toric lens Control multifocal toric lens
Active Comparator: omafilcon A Multifocal Toric Lens Control multifocal toric lens	Device: comfilcon A multifocal toric lens; contact lens; Other Names: Test Multifocal Toric Lens Biofinity multifocal toric lens ; Device: omafilcon A Multifocal Toric Lens; contact lens; Other Names: Proclear multifocal toric lens Control multifocal toric lens

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [Up to 2 hours]

   Visual Acuity (measured in LogMAR)

Secondary Outcome Measures

1. Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity [Up to 2 hours]

   Subjective assessment of visual performance for distance navigation tasks for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.

2. Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity [Up to 2 hours]

   Subjective assessment of visual performance for intermediate task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.

3. Assessment of Visual Performance: Near Task for Vision Quality and Clarity [Up to 2 hours]

   Subjective assessment of visual performance for near task for vision quality and clarity was assessed on a 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 aged 40-75 years, inclusive and has full legal capacity to volunteer.

• Has read and understood the participant information sheet.

• 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 -0.75 and -5.75DC (based on the vertexed ocular refraction in each eye.

• Can be satisfactorily fitted with the study lenses.

• Is correctable to a visual acuity of 20/40 (0.30 logMAR) or better (in each eye) with their habitual vision correction or 20/25 (0.10 logMAR) best-corrected.

• They have successfully worn soft contact lenses in the last six months

• Has clear corneas and no active ocular disease.

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

• Has an up-to-date pair of spectacles.

Exclusion Criteria:

• 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, in the opinion of the investigator, affect the wearing of contact lenses.

• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation in the study.

• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.

• Is aphakic.

• Has undergone corneal refractive surgery.

• Has a history of anaphylaxis or severe allergic reaction.

• Has diabetes or an infectious or immunosuppressive disease which could contraindicate contact lens wear or pose a risk to the investigator.

• They are pregnant or breast-feeding.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research	Manchester		United Kingdom	M13 9PL

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Philip Morgan, BSc, PhD, MCOptom, Eurolens Research

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 21, 2018

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03519282
• Other Study ID Numbers: CV-18-11
• First Posted: May 8, 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.: Yes
• Additional relevant MeSH terms: Astigmatism; Presbyopia

Study Results

Participant Flow

Pre-assignment Detail	Three subjects did not meet the inclusion criteria. Ten (10) subjects completed all visits and their data were included in the analysis.

Arm/Group Title	Test Multifocal Toric Lens Then Control Multifocal Toric	Control Multifocal Toric Lens Then Test Multifocal Toric
Arm/Group Description	Subjects were randomized to wear the test multifocal toric lens then control multifocal toric lens during this crossover study. comfilcon A multifocal toric lens: contact lens	Subjects were randomized to wear the control multifocal toric lens then test multifocal toric lens during this crossover study. omafilcon A Multifocal Toric Lens: contact lens
Period Title: First Intervention
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Comfilcon A and Omafilcon A Multifocal Toric Lenses
Arm/Group Description	Subjects were randomized to wear the comfilcon A multifocal toric (test) or omafilcon A multifocal toric (control) lens, either as first or second lens during this cross over study.
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54 (8)
Sex: Female, Male (Count of Participants)
Female	6 60%
Male	4 40%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United Kingdom	10 100%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Description	Visual Acuity (measured in LogMAR)
Time Frame	Up to 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Multifocal Toric Lens	Control Multifocal Toric Lens
Arm/Group Description	Subjects were randomized to wear the comfilcon A multifocal toric lens during this crossover study. comfilcon A multifocal toric lens: contact lens	Subjects were randomized to wear the omafilcon A Multifocal Toric Lens during this crossover study. omafilcon A Multifocal Toric Lens: contact lens
Measure Participants	10	10
Distance: Binocular	-0.08 (0.05)	-0.06 (0.10)
Distance: Monocular (dominate eye)	0.00 (0.09)	-0.01 (0.06)
Distant: Monocular (non-dominate eye)	0.02 (0.09)	0.01 (0.10)
Near: Binocular	0.10 (0.12)	0.06 (0.12)
Near: Monocular (dominate eye)	0.15 (0.17)	0.16 (0.17)
Near: Monocular (non-dominate eye)	0.17 (0.15)	0.12 (0.14)

2. Secondary Outcome

Title	Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity
Description	Subjective assessment of visual performance for distance navigation tasks for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Time Frame	Up to 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Multifocal Toric Lens	Control Multifocal Toric Lens
Arm/Group Description	Subjects were randomized to wear the comfilcon A multifocal toric lens during this crossover study. comfilcon A multifocal toric lens: contact lens	Subjects were randomized to wear the omafilcon A Multifocal Toric Lens during this crossover study. omafilcon A Multifocal Toric Lens: contact lens
Measure Participants	10	10
Mean (Standard Deviation) [units on a scale]	93 (9)	87 (16)

3. Secondary Outcome

Title	Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity
Description	Subjective assessment of visual performance for intermediate task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Time Frame	Up to 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Multifocal Toric Lens	Control Multifocal Toric Lens
Arm/Group Description	Subjects were randomized to wear the comfilcon A multifocal toric lens during this crossover study. comfilcon A multifocal toric lens: contact lens	Subjects were randomized to wear the omafilcon A Multifocal Toric Lens during this crossover study. omafilcon A Multifocal Toric Lens: contact lens
Measure Participants	10	10
Mean (Standard Deviation) [units on a scale]	95 (9)	95 (9)

4. Secondary Outcome

Title	Assessment of Visual Performance: Near Task for Vision Quality and Clarity
Description	Subjective assessment of visual performance for near task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Time Frame	Up to 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Multifocal Toric Lens	Control Multifocal Toric Lens
Arm/Group Description	Subjects were randomized to wear the comfilcon A multifocal toric lens during this crossover study. comfilcon A multifocal toric lens: contact lens	Subjects were randomized to wear the omafilcon A Multifocal Toric Lens during this crossover study. omafilcon A Multifocal Toric Lens: contact lens
Measure Participants	10	10
Mean (Standard Deviation) [units on a scale]	94 (8)	90 (20)

Adverse Events

Time Frame	Up to 2 hours
Arm/Group Title	Test Multifocal Toric Lens		Omafilcon A Multifocal Toric Lens
Arm/Group Description	Subjects were randomized to wear the comfilcon A multifocal toric lens, either as first or second lens during this crossover study. comfilcon A multifocal toric lens: contact lens omafilcon A Multifocal Toric Lens: contact lens		Subjects were randomized to wear the omafilcon A Multifocal Toric Lens, either as first or second lens during this crossover study. Control multifocal toric lens comfilcon A multifocal toric lens: contact lens omafilcon A Multifocal Toric Lens: contact lens
All Cause Mortality
	Test Multifocal Toric Lens		Omafilcon A Multifocal Toric Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Test Multifocal Toric Lens		Omafilcon A Multifocal Toric Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Test Multifocal Toric Lens		Omafilcon A Multifocal Toric Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (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.