A Clinical Comparison of Two Soft Contact Lenses

CooperVision

Status

Completed

Conditions

Myopia

Hyperopia

Treatments

Device: Lens 1 (monthly replacement)

Device: Lens 2 (daily disposable)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05741450

C22-724 (EX-MKTG-138)

Details and patient eligibility

About

The study objective was to gather short-term clinical performance data for two soft contact lenses.

Full description

The aim of this subject-masked, non-randomized, controlled non-dispensing study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact lens after 15 minutes of daily wear each.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

They are of legal age (18) and capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They currently wear soft contact lenses, or have done so within the past two years.
They are expected to be able to be fitted with the study lenses within the power range available.

Exclusion criteria

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They are aphakic.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
They are pregnant or lactating.
They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.