Lubricity Post-Wear - Competitive Lenses Pilot

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Stenfilcon A contact lenses; Device: Narafilcon A contact lenses; Device: Somofilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02402127

CLT567-P001

Details and patient eligibility

About

The purpose of this study is to measure the coefficient of friction of three silicone hydrogel, daily disposable contact lenses after 16 hours of wear.

Full description

In this 3-treatment, 3-period, 6-sequence crossover study, each participant will wear all 3 products in randomized order, 1 product at a time, with a washout period of up to 7 days between treatment periods. Lenses will be collected for ex-vivo lubricity analysis. The ex-vivo lubricity analysis will be conducted under a separate non-clinical protocol.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must sign an informed consent form.
• Soft contact lens wearer (both eyes).
• Willing to wear study lenses at least 16 waking hours and attend all study visits.
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
• Use of systemic or ocular medications for which contact lens wear could be contraindicated.
• Use of artificial tears and rewetting drops during the study.
• Monocular (only 1 eye with functional vision) or fit with only 1 lens.
• History of herpetic keratitis, ocular surgery, or irregular cornea.
• Pregnant.
• Other protocol-specified exclusion criteria may apply.

Trial design

24 participants in 6 patient groups

TruEye, MyDay, clariti 1day

Other group

Description:

Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 1 day (16 hours).

Treatment:

Device: Somofilcon A contact lenses

Device: Narafilcon A contact lenses

Device: Stenfilcon A contact lenses

TruEye, clariti 1day, MyDay

Other group

Description:

Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).

Treatment:

Device: Somofilcon A contact lenses

Device: Narafilcon A contact lenses

Device: Stenfilcon A contact lenses

MyDay, TruEye, clariti 1day

Other group

Description:

Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).

Treatment:

Device: Somofilcon A contact lenses

Device: Narafilcon A contact lenses

Device: Stenfilcon A contact lenses

MyDay, clariti 1day, TruEye

Other group

Description:

Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).

Treatment:

Device: Somofilcon A contact lenses

Device: Narafilcon A contact lenses

Device: Stenfilcon A contact lenses

Clariti 1day, TruEye, MyDay

Other group

Description:

Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).

Treatment:

Device: Somofilcon A contact lenses

Device: Narafilcon A contact lenses

Device: Stenfilcon A contact lenses

Clariti 1day, MyDay, TruEye

Other group

Description:

Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).

Treatment:

Device: Somofilcon A contact lenses

Device: Narafilcon A contact lenses

Device: Stenfilcon A contact lenses