A Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects

Study Overview
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Brief Summary
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The purpose of this study is to compare the change from baseline in central corneal curvature at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.

Detailed Description
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Participants were expected to attend 4 office visits. Visit 1 was the Screening/Enrollment visit. At Visit 2 (Baseline Visit), participants were randomized and the study lenses were trial fit. At Visit 3 (Dispense Visit), participants received study lenses for approximately 1 week of wear. Visit 4 was the Exit visit. Expected duration of participation in the study was 3 weeks.

Conditions
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Refractive Error, Myopia

Intervention / Treatment
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* Device: Delefilcon A contact lens
* Device: Narafilcon A contact lens
* Device: Spectacles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign Informed Consent document; Higher degree of myopia in both eyes, i.e. habitual contact lens power between -10.00 diopters (D) and -17.00D; Best corrected distance visual acuity greater than or equal to 20/30 in each eye (measured with either spectacle refraction or habitual contact lenses plus over refraction); Manifest astigmatism less than or equal to -1.00D; Soft contact lens wear in both eyes at least 5 days per week and at least 8 hours per day; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Pregnant or lactating; Eye injury or surgery within twelve weeks immediately prior to enrollment; Any ocular condition that contraindicates contact lens wear; History of herpetic keratitis; Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including any use of topical ocular medications that would require instillation during contact lens wear, except for approved lubricating drops; Clinical significant dry eye not responding to treatment; Previous corneal or refractive surgery or irregular cornea; Requires reading glasses; Participation in a clinical trial (including contact lens or contact lens care product) within the previous 30 days; Wears habitual lenses in an extended wear modality (routinely sleeps in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment; Other protocol-defined 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAILIES TOTAL1<br>Delefilcon A contact lens randomly assigned to one eye, with narafilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision. | Device: Delefilcon A contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: DAILIES® TOTAL1®;Device: Narafilcon A contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: 1-DAY ACUVUE TRUEYE™;Device: Spectacles<br>* Incremental prescription worn over contact lenses if needed to provide acceptable vision<br>|
| Active Comparator: TRUEYE<br>Narafilcon A contact lens randomly assigned to one eye, with delefilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision. | Device: Delefilcon A contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: DAILIES® TOTAL1®;Device: Narafilcon A contact lens<br>* Commercially available silicone hydrogel contact lens<br>* Other names: 1-DAY ACUVUE TRUEYE™;Device: Spectacles<br>* Incremental prescription worn over contact lenses if needed to provide acceptable vision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Central Corneal Curvature From Dispense at Week 1 | Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening. | Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1 | Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction. | Baseline, Week 1 (Day 8 of lens wear) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lenses, Nearsightedness, Corneal curvature, K-reading, High minus, Spectacle refraction