Back to resultsClinical Evaluation of Investigational Multifocal Toric Contact Lenses
Primary Purpose
Presbyopia, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
comfilcon A multifocal toric lens
omafilcon A Multifocal Toric Lens
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
Eligibility Criteria
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.
Sites / Locations
- Eurolens Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test Multifocal Toric Lens
omafilcon A Multifocal Toric Lens
Arm Description
comfilcon A multifocal toric lens
Control multifocal toric lens
Outcomes
Primary Outcome Measures
Visual Acuity
Visual Acuity (measured in LogMAR)
Secondary Outcome Measures
Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity
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.
Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity
Subjective assessment of visual performance for intermediate task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Assessment of Visual Performance: Near Task for Vision Quality and Clarity
Subjective assessment of visual performance for near task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03519282
Brief Title
Clinical Evaluation of Investigational Multifocal Toric Contact Lenses
Official Title
Clinical Evaluation of Biofinity Multifocal Toric Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
July 24, 2018 (Actual)
Study Completion Date
July 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. 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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Multifocal Toric Lens
Arm Type
Experimental
Arm Description
comfilcon A multifocal toric lens
Arm Title
omafilcon A Multifocal Toric Lens
Arm Type
Active Comparator
Arm Description
Control multifocal toric lens
Intervention Type
Device
Intervention Name(s)
comfilcon A multifocal toric lens
Other Intervention Name(s)
Test Multifocal Toric Lens, Biofinity multifocal toric lens
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
omafilcon A Multifocal Toric Lens
Other Intervention Name(s)
Proclear multifocal toric lens, Control multifocal toric lens
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Visual Acuity (measured in LogMAR)
Time Frame
Up to 2 hours
Secondary Outcome Measure Information:
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Morgan, BSc, PhD, MCOptom
Organizational Affiliation
Eurolens Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurolens Research
City
Manchester
ZIP/Postal Code
M13 9PL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of Investigational Multifocal Toric Contact Lenses
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