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Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Not Applicable
Completed
Conditions
Refractive Errors
Myopia
Interventions
Device: verofilcon A contact lenses
Device: somofilcon A contact lenses
Registration Number
NCT03518008
Lead Sponsor
Alcon Research
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
22
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
DD T2, then Clariti 1 Dayverofilcon A contact lensesVerofilcon 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.
DD T2, then Clariti 1 Daysomofilcon A contact lensesVerofilcon 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.
Clariti 1 Day, then DD T2somofilcon A contact lensesSomofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality.
Clariti 1 Day, then DD T2verofilcon A contact lensesSomofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality.
Primary Outcome Measures
NameTimeMethod
Overall Quality of VisionDay 8, each product

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Alcon Investigative Site

🇺🇸

Maitland, Florida, United States

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