Clinical Evaluation of Investigational Multifocal Toric Contact Lenses

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.