Clinical Comparison of 4 Daily Disposable Soft Contact Lenses

Not Applicable

Completed

• Conditions: Refractive Error
• Interventions: Device: verofilcon A contact lenses; Device: senofilcon A contact lenses; Device: stenfilcon A contact lenses; Device: etafilcon A contact lenses

• Registration Number: NCT03349632
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.

Detailed Description

The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.

Study Timeline

• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-21
• Study Start: 2018-01-10
• Primary Completion: 2018-02-16
• Study Completion: 2018-02-16
• Status Verified: 2019-01
• Results First Submitted: 2019-01-30
• Results First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Results First Posted: 2019-02-22
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Able to understand and must sign an approved Informed Consent Form
• Successfully wears 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 of 20/25 Snellen or better in each eye
• Willing to stop wearing habitual contact lenses for the duration of study participation
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria

• Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.
• Routinely sleeps in habitual contact lenses
• Currently wears Oasys 1-Day, MyDay, or Moist contact lenses
• Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DD T2/Oasys 1-Day	verofilcon A contact lenses	Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized
DD T2/Oasys 1-Day	senofilcon A contact lenses	Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized
DD T2/MyDay	verofilcon A contact lenses	Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
DD T2/MyDay	stenfilcon A contact lenses	Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
DD T2/Moist	verofilcon A contact lenses	Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized
DD T2/Moist	etafilcon A contact lenses	Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized

Primary Outcome Measures

Name	Time	Method
Overall Quality of Vision	Day 8, each product	Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.

Trial Locations

Locations (1)

Alcon Investigative Site; 🇺🇸 Johns Creek, Georgia, United States