Clinical Evaluation of Invigor Toric 1-Day Contact Lenses

CooperVision

Status: Completed

Conditions: Astigmatism

Treatments: Device: 1-day toric test contact lens; Device: 1-day toric control contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT04016623

CV-19-27

Details and patient eligibility

About

An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.

Full description

A non-dispensing, double-masked, randomized, contralateral study comparing the 1-day toric test contact lens against the 1-day toric control contact lens to evaluate the clinical performance over one hour of lens wear. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye for each pair of lenses.

Each subject will be asked to wear four pairs of contact lenses in the study

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has had a self-reported oculo-visual examination in the last two years.
• Is at least 18 years of age and has full legal capacity to volunteer.
• Has read and understood the information consent letter.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
• Currently wears soft contact lenses.
• Has clear corneas and no active ocular disease.
• Has not worn lenses for at least 12 hours before the examination

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 affect the wearing of contact lenses.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
• Is aphakic.
• Has undergone corneal refractive surgery.
• Is participating in any other type of eye related clinical or research study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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10 participants in 2 patient groups

1-day toric test contact lens

Experimental group

Description:

Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens).

Treatment:

Device: 1-day toric control contact lens

Device: 1-day toric test contact lens

1-day toric control contact lens

Active Comparator group

Description:

Each subject will wear the 1-day toric test (Test) lens in one eye and 1-day toric control (Control) contact lens in the other eye. Patient will wear as an unmatched pair, per predetermined randomization schedule (to determine which eye receives the Test or Control contact lens).

Treatment:

Device: 1-day toric control contact lens

Device: 1-day toric test contact lens