CompletedNCT03518008Updated Apr 3, 2019Results posted

Clinical Comparison of Two Daily Disposable Soft Contact Lenses

An interventional study of verofilcon A contact lenses and somofilcon A contact lenses in Myopia and Refractive Errors, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-03.

Sponsored by Alcon Research · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 22
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.

Conditions studied

Myopia
Refractive Errors

Browse trials for

Refractive Errors 413

Keywords

soft contact lenses
vision
eyesight

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 22 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

Understand and sign an Informed Consent Form;
Successful wear of daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
Willing to stop wearing habitual contact lenses for the duration of study participation;
Other protocol-specified inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator;
Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
Refractive, ocular, or intraocular surgery, as specified in the protocol;
Eye condition or injury, as specified in the protocol;
Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;
Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
Currently wearing clariti® 1 day contact lenses;
Habitually wearing monovision or multifocal lenses during the last 3 months;
Other protocol-specified exclusion criteria may apply.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 22 participants (actual)

Study arms

Other
DD T2, then Clariti 1 Day
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality.
Device: verofilcon A contact lenses · Device: somofilcon A contact lenses
Other
Clariti 1 Day, then DD T2
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality.
Device: verofilcon A contact lenses · Device: somofilcon A contact lenses

Interventions

Deviceverofilcon A contact lenses
Investigational daily disposable soft contact lenses
Also known as: DD T2
Devicesomofilcon A contact lenses
Commercially available daily disposable soft contact lenses
Also known as: clariti® 1 day, Clariti 1 Day

What researchers measure

Primary outcomes

Overall Quality of Vision
Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.
Time frame: Day 8, each product

Results

Posted Apr 3, 2019

Participant flow

Subjects were recruited from 1 investigative site located in the United States.

Period 1, First Week of Wear

Participant flow — Period 1, First Week of Wear
Milestone	DDT2, Then Clariti 1 Day	Clariti 1 Day, Then DDT2
Started	11	11
Completed	11	11
Not completed	0	0

Period 2, Second Week of Wear

Participant flow — Period 2, Second Week of Wear
Milestone	DDT2, Then Clariti 1 Day	Clariti 1 Day, Then DDT2
Started	11	11
Completed	11	10
Not completed	0	1
Withdrew: Family emergency	0	1

Outcome measures

PrimaryOverall Quality of Vision

Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.

Time frame:: Day 8, each product
Reported as:: Mean · units on a scale

Overall Quality of Vision
units on a scale	DD T2	Clariti 1 Day
Overall Quality of Vision	9.2 ± 1.0	8.6 ± 1.5

Adverse events

Collected over Dispense through study completion, approximately 20 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
DD T2	0/22 (0%)	0/22 (0%)	0/22 (0%)
Clariti 1 Day	0/22 (0%)	0/22 (0%)	0/22 (0%)

Baseline characteristics

This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study (Safety Analysis Set).

Age, Continuous
Age, Continuous(years)	Overall
Mean	32.1 ± 6.4

Sex: Female, Male
Sex: Female, Male(Participants)	Overall
Female	14
Male	8

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Overall
Hispanic or Latino	3
Not Hispanic or Latino	19
Unknown or Not Reported	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Overall
White	22
Black or African American	0
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Other	0

Study locations

1 site

Alcon Investigative Site
Maitland, Florida 32751, United States

References and documents

Study documents

Study protocol · Apr 20, 2018
Statistical analysis plan · Apr 30, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03518008
Lead sponsor: Alcon Research
Responsible party: Sponsor
First posted: May 8, 2018
Start date: May 23, 2018
Primary completion: Jun 11, 2018
Completion: Jun 11, 2018
Results posted: Apr 3, 2019
Last update: Apr 3, 2019

Study contacts

Alcon Research

study director · Alcon Research

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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