Clinical Validation of the New Print on Focus DAILIES Toric

Study Overview
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Brief Summary
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The purpose of this study is to validate the improvements to the inversion indicator.

Detailed Description
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This study was conducted in three countries under three separate protocols: P-346-C-009 sub 02 (UK), P-346-C-009 sub 03 (Germany), and P-346-C-010 (USA). The data reported represents pooled data from the three protocols.

Conditions
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Myopia

Intervention / Treatment
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* Device: nelfilcon A contact lens, modified inversion indicator
* Device: nelfilcon A contact lens, no inversion indicator
* Device: nelfilcon A contact lens, inversion indicator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be of legal age and sign written Informed Consent Document. If under legal age, parent or guardian must sign Informed Consent Document and subjects ages 12 through 17 must sign Informed Assent. Willing and able to wear study lenses in both eyes in the available parameters. Light-eyed subjects. Able to achieve 20/40 or better distance visual acuity (VA) in each eye at time of dispensing. Optimal or acceptable fit in each eye at time of dispensing. Willing to wear the study lenses at least 8 hours a day, 5 days a week. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks prior to enrollment for this trial. Pre-existing ocular irritation that would preclude contact lens fitting. Currently enrolled in an ophthalmic clinical trial. Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator. Any use of medications for which contact lens wear could be contraindicated as determined by the investigator. RGP contact lens wearer. Other protocol-defined exclusion criteria may apply.
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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nelfilcon A, modified inversion indicator<br>Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week | Device: nelfilcon A contact lens, modified inversion indicator<br>* Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator<br>|
| Experimental: nelfilcon A, no inversion indicator<br>Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week | Device: nelfilcon A contact lens, no inversion indicator<br>* Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator<br>|
| Active Comparator: nelfilcon A, inversion indicator<br>Nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week. | Device: nelfilcon A contact lens, inversion indicator<br>* Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator<br>* Other names: Focus DAILIES Toric;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion. | As assessed by the participant retrospectively after one week of wear and recorded on a questionnaire as a yes or no response to the question, Did you notice an OK mark on the study lens while it was on your finger, for example, during lens insertion? The positive yes responses are reported. | 1 week |