A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: somofilcon A; Device: stenfilcon A; Device: comfilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT04005885

EX-MKTG-100

Details and patient eligibility

About

This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.

Full description

This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.

Enrollment: 55 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects will only be eligible for the study if:
• They are between 18 and 40 years of age (inclusive).
• 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 are an existing soft reusable spherical contact lens wearer in both eyes.
• They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction.
• They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction
• They own a wearable pair of spectacles and wear them on the day of the initial visit.
• They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles.
• They agree not to participate in other clinical research for the duration of the study.

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 breastfeeding.
• They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
• They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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55 participants in 2 patient groups

somofilcon A then stenfilcon A contact lens

Experimental group

Description:

Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear.

Treatment:

Device: stenfilcon A

Device: comfilcon A

Device: somofilcon A

stenfilcon A then somofilcon A contact lens

Experimental group

Description:

Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear.

Treatment:

Device: stenfilcon A

Device: comfilcon A

Device: somofilcon A