Lubricity Post-Wear - Competitive Lenses Pilot

NCT ID: NCT02402127

Last Updated: 2016-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-07-31

Brief Summary

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.

Detailed 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.

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

TruEye, MyDay, clariti 1day

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).

Group Type: OTHER

Narafilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Stenfilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Somofilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

TruEye, clariti 1day, MyDay

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).

Group Type: OTHER

Narafilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Stenfilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Somofilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

MyDay, TruEye, clariti 1day

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).

Group Type: OTHER

Narafilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Stenfilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Somofilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

MyDay, clariti 1day, TruEye

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).

Group Type: OTHER

Narafilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Stenfilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Somofilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Clariti 1day, TruEye, MyDay

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).

Group Type: OTHER

Narafilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Stenfilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Somofilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Clariti 1day, MyDay, TruEye

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).

Group Type: OTHER

Narafilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Stenfilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Somofilcon A contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Interventions

Narafilcon A contact lenses

Silicone hydrogel contact lenses for daily disposable wear

Intervention Type: DEVICE

Stenfilcon A contact lenses

Silicone hydrogel contact lenses for daily disposable wear

Intervention Type: DEVICE

Somofilcon A contact lenses

Silicone hydrogel contact lenses for daily disposable wear

Intervention Type: DEVICE

Other Intervention Names

1-DAY ACUVUE® TruEye® (TruEye); MyDay™; clariti® 1day

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Manager, Vision Care, Global Medical Affairs

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

CLT567-P001

Identifier Type: -

Identifier Source: org_study_id