Lubricity Post-Wear - Competitive Lenses Pilot

NCT02402127 | Completed Results

• 1 other identifier: CLT567-P001
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error

Keywords

Contact lenses; Lubricity

Outcome Measures

Primary Outcomes (1)

• Average Coefficient of Friction of Worn Lenses at 16 Hours

  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.

  Day 1, Hour 16, each product

Secondary Outcomes (1)

• Average Coefficient of Friction of Unworn Lenses

  Day 1 (each product)

Study Arms (6)

TruEye, MyDay, clariti 1day

OTHER

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).

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

TruEye, clariti 1day, MyDay

OTHER

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).

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

MyDay, TruEye, clariti 1day

OTHER

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).

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

MyDay, clariti 1day, TruEye

OTHER

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).

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

Clariti 1day, TruEye, MyDay

OTHER

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).

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

Clariti 1day, MyDay, TruEye

OTHER

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).

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

Interventions

Narafilcon A contact lenses DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Also known as: 1-DAY ACUVUE® TruEye® (TruEye)

Clariti 1day, MyDay, TruEye; Clariti 1day, TruEye, MyDay; MyDay, TruEye, clariti 1day; MyDay, clariti 1day, TruEye; TruEye, MyDay, clariti 1day; TruEye, clariti 1day, MyDay

Stenfilcon A contact lenses DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Also known as: MyDay™

Clariti 1day, MyDay, TruEye; Clariti 1day, TruEye, MyDay; MyDay, TruEye, clariti 1day; MyDay, clariti 1day, TruEye; TruEye, MyDay, clariti 1day; TruEye, clariti 1day, MyDay

Somofilcon A contact lenses DEVICE

Silicone hydrogel contact lenses for daily disposable wear

Also known as: clariti® 1day

Clariti 1day, MyDay, TruEye; Clariti 1day, TruEye, MyDay; MyDay, TruEye, clariti 1day; MyDay, clariti 1day, TruEye; TruEye, MyDay, clariti 1day; TruEye, clariti 1day, MyDay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Global Medical Affairs Franchise Head, Vision Care
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, Vision Care, Global Medical Affairs

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: March 30, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 2, 2016
• Results First Posted: September 2, 2016

Record last verified: 2016-07