Lubricity Post-Wear - Competitive Lenses Pilot

Not Applicable

Completed

• Conditions: Refractive Error
• Interventions: Device: Narafilcon A contact lenses; Device: Stenfilcon A contact lenses; Device: Somofilcon A contact lenses

• Registration Number: NCT02402127
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-30
• Study Start: 2015-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-07
• Results First Submitted: 2016-07-25
• Results First Submitted QC: 2016-07-25
• Last Update Submitted: 2016-07-25
• Results First Posted: 2016-09-02
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MyDay, TruEye, clariti 1day	Narafilcon A contact lenses	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).
MyDay, TruEye, clariti 1day	Stenfilcon A contact lenses	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).
TruEye, clariti 1day, MyDay	Stenfilcon A contact lenses	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).
MyDay, clariti 1day, TruEye	Stenfilcon A contact lenses	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).
Clariti 1day, TruEye, MyDay	Narafilcon A contact lenses	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).
TruEye, MyDay, clariti 1day	Stenfilcon A contact lenses	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).
TruEye, MyDay, clariti 1day	Narafilcon A contact lenses	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).
TruEye, clariti 1day, MyDay	Narafilcon A contact lenses	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).
TruEye, clariti 1day, MyDay	Somofilcon A contact lenses	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).
TruEye, MyDay, clariti 1day	Somofilcon A contact lenses	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).
MyDay, TruEye, clariti 1day	Somofilcon A contact lenses	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).
MyDay, clariti 1day, TruEye	Narafilcon A contact lenses	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).
Clariti 1day, TruEye, MyDay	Somofilcon A contact lenses	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).
Clariti 1day, MyDay, TruEye	Narafilcon A contact lenses	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).
Clariti 1day, MyDay, TruEye	Somofilcon A contact lenses	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).
MyDay, clariti 1day, TruEye	Somofilcon A contact lenses	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).
Clariti 1day, TruEye, MyDay	Stenfilcon A contact lenses	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).
Clariti 1day, MyDay, TruEye	Stenfilcon A contact lenses	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).

Primary Outcome Measures

Name	Time	Method
Average Coefficient of Friction of Worn Lenses at 16 Hours	Day 1, Hour 16, each product	Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.

Secondary Outcome Measures

Name	Time	Method
Average Coefficient of Friction of Unworn Lenses	Day 1 (each product)	Unworn contact lenses were removed from the commercial packaging and the coefficient of friction of the unworn lenses was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity.