CompletedNCT02402127Updated Sep 2, 2016Results posted

Lubricity Post-Wear - Competitive Lenses Pilot

An interventional study of Narafilcon A contact lenses and Stenfilcon A contact lenses in Refractive Error, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-02.

Sponsored by Alcon Research · Not applicable and Interventional

Phase: Not applicable
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 studied

Refractive Error

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Refractive Errors 413

Keywords

Contact lenses
Lubricity

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 24 is below the median of 82 across 296 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Outcomes assessor)
Enrollment: 24 participants (actual)

Study arms

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 · Device: Stenfilcon A contact lenses · Device: Somofilcon A contact lenses
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 · Device: Stenfilcon A contact lenses · Device: Somofilcon A contact lenses
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 · Device: Stenfilcon A contact lenses · Device: Somofilcon A contact lenses
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 · Device: Stenfilcon A contact lenses · Device: Somofilcon A contact lenses
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 · Device: Stenfilcon A contact lenses · Device: Somofilcon A contact lenses
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 · Device: Stenfilcon A contact lenses · Device: Somofilcon A contact lenses

Interventions

DeviceNarafilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Also known as: 1-DAY ACUVUE® TruEye® (TruEye)
DeviceStenfilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Also known as: MyDay™
DeviceSomofilcon A contact lenses
Silicone hydrogel contact lenses for daily disposable wear
Also known as: clariti® 1day

What researchers measure

Primary outcomes

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.
Time frame: Day 1, Hour 16, each product

Secondary outcomes

Average Coefficient of Friction of Unworn Lenses
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.
Time frame: Day 1 (each product)

Results

Posted Sep 2, 2016

Participant flow

Participants were recruited from three investigational centers located in the United States.

First Wear Period (1 Day)

Participant flow — First Wear Period (1 Day)
Milestone	TruEye, MyDay, Clariti 1day	TruEye, Clariti 1day, MyDay	MyDay, TruEye, Clariti 1day	MyDay, Clariti 1day, TruEye	Clariti 1day, TruEye, MyDay	Clariti 1day, MyDay, TruEye
Started	4	4	4	4	4	4
Randomized and treated	4	4	4	4	4	4
Completed	4	4	4	4	4	4
Not completed	0	0	0	0	0	0

Second Wear Period (1 Day)

Participant flow — Second Wear Period (1 Day)
Milestone	TruEye, MyDay, Clariti 1day	TruEye, Clariti 1day, MyDay	MyDay, TruEye, Clariti 1day	MyDay, Clariti 1day, TruEye	Clariti 1day, TruEye, MyDay	Clariti 1day, MyDay, TruEye
Started	4	4	4	4	4	4
Completed	4	4	4	4	4	4
Not completed	0	0	0	0	0	0

Third Wear Period (1 Day)

Participant flow — Third Wear Period (1 Day)
Milestone	TruEye, MyDay, Clariti 1day	TruEye, Clariti 1day, MyDay	MyDay, TruEye, Clariti 1day	MyDay, Clariti 1day, TruEye	Clariti 1day, TruEye, MyDay	Clariti 1day, MyDay, TruEye
Started	4	4	4	4	4	4
Completed	4	4	4	4	4	4
Not completed	0	0	0	0	0	0

Outcome measures

PrimaryAverage 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.

Time frame:: Day 1, Hour 16, each product
Reported as:: Mean · unitless

Average Coefficient of Friction of Worn Lenses at 16 Hours
unitless	TruEye	MyDay	Clariti 1day
Average Coefficient of Friction of Worn Lenses at 16 Hours	0.0602 ± 0.00474	0.0576 ± 0.00338	0.0578 ± 0.00439

SecondaryAverage Coefficient of Friction of Unworn Lenses

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.

Time frame:: Day 1 (each product)
Reported as:: Mean · unitless

Average Coefficient of Friction of Unworn Lenses
unitless	TruEye	MyDay	Clariti 1day
Average Coefficient of Friction of Unworn Lenses	0.0571 ± 0.00324	0.0571 ± 0.00260	0.0552 ± 0.00305

Adverse events

Collected over Adverse events (AEs) were collected for the duration of the study from the signing of informed consent (up to 17 days). This analysis population includes all participants exposed to investigational product.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
TruEye	—	0/24 (0%)	0/24 (0%)
MyDay	—	0/24 (0%)	0/24 (0%)
Clariti 1day	—	0/24 (0%)	0/24 (0%)

Baseline characteristics

Intention to treat, defined as the set of all randomized participants

Age, Continuous
Age, Continuous(years)	TruEye, MyDay, Clariti 1day	TruEye, Clariti 1day, MyDay	MyDay, TruEye, Clariti 1day	MyDay, Clariti 1day, TruEye	Clariti 1day, TruEye, MyDay	Clariti 1day, MyDay, TruEye	Total
Mean	34.0 ± 9.6	27.5 ± 4.0	33.0 ± 7.3	35.3 ± 4.6	26.3 ± 6.2	24.3 ± 2.4	30.0 ± 6.9

Age, Customized
Age, Customized(participants)	TruEye, MyDay, Clariti 1day	TruEye, Clariti 1day, MyDay	MyDay, TruEye, Clariti 1day	MyDay, Clariti 1day, TruEye	Clariti 1day, TruEye, MyDay	Clariti 1day, MyDay, TruEye	Total
18-64 years	4	4	4	4	4	4	24
≥65 years	0	0	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	TruEye, MyDay, Clariti 1day	TruEye, Clariti 1day, MyDay	MyDay, TruEye, Clariti 1day	MyDay, Clariti 1day, TruEye	Clariti 1day, TruEye, MyDay	Clariti 1day, MyDay, TruEye	Total
Female	2	2	3	2	4	2	15
Male	2	2	1	2	0	2	9

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02402127
Lead sponsor: Alcon Research
Responsible party: Sponsor
First posted: Mar 30, 2015
Start date: May 2015
Primary completion: Jul 2015
Completion: Jul 2015
Results posted: Sep 2, 2016
Last update: Sep 2, 2016

Study contacts

Clinical Manager, Vision Care, Global Medical Affairs

study director · Alcon Research

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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