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Clinical Evaluation of Investigational Multifocal Toric Contact Lenses

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CooperVision

Status

Completed

Conditions

Astigmatism
Presbyopia

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT03519282
CV-18-11

Details and patient eligibility

About

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).

Full 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).

Enrollment

13 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

13 participants in 2 patient groups

Test Multifocal Toric Lens
Experimental group
Description:
comfilcon A multifocal toric lens
Treatment:
Device: comfilcon A multifocal toric lens
Device: omafilcon A Multifocal Toric Lens
omafilcon A Multifocal Toric Lens
Active Comparator group
Description:
Control multifocal toric lens
Treatment:
Device: comfilcon A multifocal toric lens
Device: omafilcon A Multifocal Toric Lens

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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