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Clinical Comparison of Two Daily Disposable Soft Contact Lenses

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Alcon

Status

Completed

Conditions

Myopia
Refractive Errors

Treatments

Device: somofilcon A contact lenses
Device: verofilcon A contact lenses

Study type

Interventional

Funder types

Industry

Identifiers

NCT03518008
CLE383-C006

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

22 participants in 2 patient groups

DD T2, then Clariti 1 Day
Other group
Description:
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.
Treatment:
Device: verofilcon A contact lenses
Device: somofilcon A contact lenses
Clariti 1 Day, then DD T2
Other group
Description:
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.
Treatment:
Device: verofilcon A contact lenses
Device: somofilcon A contact lenses

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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