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CompletedNCT03519282Updated May 4, 2020Results posted

Clinical Evaluation of Investigational Multifocal Toric Contact Lenses

An interventional study of comfilcon A multifocal toric lens and omafilcon A Multifocal Toric Lens in Presbyopia and Astigmatism, sponsored by CooperVision International Limited (CVIL). Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-04.

Sponsored by CooperVision International Limited (CVIL) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Presbyopia
  • Astigmatism
03

In context

Astigmatism

413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.

This study's enrollment of 13 is below the median of 55 across 321 interventional studies indexed under Astigmatism.

Browse Astigmatism studies →

Lead sponsor

CooperVision International Limited (CVIL) is the lead sponsor of 138 studies on the registry; 9 are open to participants now.

Of its 72 completed or terminated interventional studies of FDA-regulated products, 67 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Test Multifocal Toric Lens

    comfilcon A multifocal toric lens

    Device: comfilcon A multifocal toric lens · Device: omafilcon A Multifocal Toric Lens

  • Active comparator
    omafilcon A Multifocal Toric Lens

    Control multifocal toric lens

    Device: comfilcon A multifocal toric lens · Device: omafilcon A Multifocal Toric Lens

Interventions

  • Devicecomfilcon A multifocal toric lens

    contact lens

    Also known as: Test Multifocal Toric Lens, Biofinity multifocal toric lens

  • Deviceomafilcon A Multifocal Toric Lens

    contact lens

    Also known as: Proclear multifocal toric lens, Control multifocal toric lens

06

What researchers measure

Primary outcomes

  1. Visual Acuity

    Visual Acuity (measured in LogMAR)

    Time frame: Up to 2 hours

Secondary outcomes

  1. 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.

    Time frame: Up to 2 hours

  2. 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.

    Time frame: Up to 2 hours

  3. 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.

    Time frame: Up to 2 hours

07

Results

Posted May 4, 2020

Participant flow

First Intervention
Participant flow — First Intervention
MilestoneTest Multifocal Toric Lens Then Control Multifocal ToricControl Multifocal Toric Lens Then Test Multifocal Toric
Started55
Completed55
Not completed00
Second Intervention
Participant flow — Second Intervention
MilestoneTest Multifocal Toric Lens Then Control Multifocal ToricControl Multifocal Toric Lens Then Test Multifocal Toric
Started55
Completed55
Not completed00

Outcome measures

PrimaryVisual Acuity

Visual Acuity (measured in LogMAR)

Time frame:
Up to 2 hours
Reported as:
Mean · logMAR
Visual Acuity
logMARTest Multifocal Toric LensControl Multifocal Toric Lens
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 ± 0.090.01 ± 0.10
Near: Binocular0.10 ± 0.120.06 ± 0.12
Near: Monocular (dominate eye)0.15 ± 0.170.16 ± 0.17
Near: Monocular (non-dominate eye)0.17 ± 0.150.12 ± 0.14
SecondaryAssessment 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.

Time frame:
Up to 2 hours
Reported as:
Mean · units on a scale
Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity
units on a scaleTest Multifocal Toric LensControl Multifocal Toric Lens
Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity93 ± 987 ± 16
SecondaryAssessment 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.

Time frame:
Up to 2 hours
Reported as:
Mean · units on a scale
Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity
units on a scaleTest Multifocal Toric LensControl Multifocal Toric Lens
Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity95 ± 995 ± 9
SecondaryAssessment 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.

Time frame:
Up to 2 hours
Reported as:
Mean · units on a scale
Assessment of Visual Performance: Near Task for Vision Quality and Clarity
units on a scaleTest Multifocal Toric LensControl Multifocal Toric Lens
Assessment of Visual Performance: Near Task for Vision Quality and Clarity94 ± 890 ± 20

Adverse events

Collected over Up to 2 hours. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test Multifocal Toric Lens0/10 (0%)0/10 (0%)0/10 (0%)
Omafilcon A Multifocal Toric Lens0/10 (0%)0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Comfilcon A and Omafilcon A Multifocal Toric Lenses
Mean54 ± 8
Sex: Female, Male
Sex: Female, Male(Participants)Comfilcon A and Omafilcon A Multifocal Toric Lenses
Female6
Male4
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Comfilcon A and Omafilcon A Multifocal Toric Lenses
Region of Enrollment
Region of Enrollment(participants)Comfilcon A and Omafilcon A Multifocal Toric Lenses
United Kingdom10
08

Study locations

1 site
  • Eurolens Research
    Manchester, M13 9PL, United Kingdom
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 21, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03519282
Lead sponsor
CooperVision International Limited (CVIL)
Responsible party
Sponsor
First posted
May 8, 2018
Start date
Apr 25, 2018
Primary completion
Jul 24, 2018
Completion
Jul 24, 2018
Results posted
May 4, 2020
Last update
May 4, 2020

Study contacts

Philip Morgan, BSc, PhD, MCOptom
principal investigator · Eurolens Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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