Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 2 weeks of daily wear.

Detailed Description
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Participants will attend a Screening visit, a Dispense visit (0 to 4 days later), and a follow-up visit approximately 2 weeks after the Dispense visit.

Official Title
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Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: Lehfilcon A contact lenses
* Device: Multipurpose disinfection solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understand and sign an Informed Consent that has been approved by an Institutional Review Board. Successful wear of spherical weekly/monthly soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months. Willing to stop wearing habitual contact lenses for the duration of study participation. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any condition that contraindicates contact lens wear, as determined by the Investigator. Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator. History of refractive surgery or plan to have refractive surgery during the study. Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear. Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. Any use of topical ocular medications or artificial tear or rewetting drops that would require instillation during contact lens wear. Monovision or multifocal contact lens wear. 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LID020098<br>Lehfilcon A contact lenses worn in both eyes for 2 weeks. Lenses will be removed nightly for cleaning and disinfection. | Device: Lehfilcon A contact lenses<br>* Silicone hydrogel contact lenses with investigational coating<br>* Other names: LID020098;Device: Multipurpose disinfection solution<br>* Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses<br>* Other names: OPTI-FREE® RepleniSH®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Front Surface Wettability, by Category | Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed. | Dispense; Week 2 Follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vision, Contact lenses