Lubricity Post-Wear - Competitive Lenses Pilot

July 25, 2016 updated by: Alcon Research

Evaluation of the Lubricity of Daily Disposable Silicone Hydrogel Contact Lenses After Wear

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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).
Device: Narafilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • 1-DAY ACUVUE® TruEye® (TruEye)
Device: Stenfilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • MyDay™
Device: Somofilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • clariti® 1day
Other: 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).
Device: Narafilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • 1-DAY ACUVUE® TruEye® (TruEye)
Device: Stenfilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • MyDay™
Device: Somofilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • clariti® 1day
Other: 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).
Device: Narafilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • 1-DAY ACUVUE® TruEye® (TruEye)
Device: Stenfilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • MyDay™
Device: Somofilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • clariti® 1day
Other: 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).
Device: Narafilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • 1-DAY ACUVUE® TruEye® (TruEye)
Device: Stenfilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • MyDay™
Device: Somofilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • clariti® 1day
Other: 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).
Device: Narafilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • 1-DAY ACUVUE® TruEye® (TruEye)
Device: Stenfilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • MyDay™
Device: Somofilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • clariti® 1day
Other: 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).
Device: Narafilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • 1-DAY ACUVUE® TruEye® (TruEye)
Device: Stenfilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • MyDay™
Device: Somofilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Other Names:
  • clariti® 1day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Coefficient of Friction of Worn Lenses at 16 Hours
Time Frame: 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.
Day 1, Hour 16, each product

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Coefficient of Friction of Unworn Lenses
Time Frame: 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.
Day 1 (each product)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Manager, Vision Care, Global Medical Affairs, Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

September 2, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLT567-P001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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