Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

Study Overview
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Brief Summary
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The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.

Detailed Description
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Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.

Official Title
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Clinical Safety and Effectiveness Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens

Conditions
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Refractive Ametropia

Intervention / Treatment
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* Device: LID015385 soft contact lenses
* Device: Comfilcon A soft contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and sign an Informed Consent Form. Willing to attend all scheduled study visits as required per protocol. Willing and able to wear assigned study lenses as required per protocol. Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week. Manifest cylinder ≤ 0.75 diopter (D) in each eye. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator. Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator. History of eye surgery, including refractive surgery. Currently pregnant or breast-feeding. Monovision contact lens wearers. Daily disposable contact lens wearers. 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LID015385<br>LID015385 soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol. | Device: LID015385 soft contact lenses<br>* Investigational silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear<br>|
| Active Comparator: Biofinity<br>Comfilcon A soft contact lenses worn in both eyes for up to 6 nights/7 days continuously (awake and asleep). Must sleep 1 night per week without lenses. Lenses will be replaced as specified in the study protocol. | Device: Comfilcon A soft contact lenses<br>* Silicone hydrogel contact lenses for up to 6 nights/7 days of continuous wear<br>* Other names: BIOFINITY®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Visual Acuity (VA) With Study Lenses - Completed Eyes | Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed. | Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up | 
| Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes | Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed. | Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up | 
| Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs) | Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity). | Up to Month 12 |