Performance Assessment of a Modified Daily Disposable Contact Lens

Study Overview
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Brief Summary
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The purpose of this study is to compare visual acuity between two daily disposable contact lenses.

Detailed Description
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The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.

Official Title
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Performance Assessment of a Modified Daily Disposable Contact Lens

Conditions
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Refractive Errors, Myopia, Hyperopia

Intervention / Treatment
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* Device: Modified delefilcon A contact lenses
* Device: Delefilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and sign an approved Informed Consent form; Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any eye condition that contraindicates contact lens wear, as determined by the Investigator; Any eye surgery that contraindicates contact lens wear, as determined by the Investigator; Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) Monocular (only one eye with functional vision); Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MDACL, then DACL<br>Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality. | Device: Modified delefilcon A contact lenses<br>* Spherical soft daily disposable contact lens<br>* Other names: MDACL;Device: Delefilcon A contact lenses<br>* Spherical soft daily disposable contact lens<br>* Other names: DACL;|
| Other: DACL, then MDACL<br>DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality. | Device: Modified delefilcon A contact lenses<br>* Spherical soft daily disposable contact lens<br>* Other names: MDACL;Device: Delefilcon A contact lenses<br>* Spherical soft daily disposable contact lens<br>* Other names: DACL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Contrast Distance Visual Acuity (logMAR) | Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA. | Day 1 Dispense, Day 7 Follow-Up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lens, Vision correction, Visual acuity