Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 7 days of daily wear.

Detailed Description
-----------------
Participants will attend a Screening visit, a Dispense visit, and a Week 1 Follow-up/exit visit.

Official Title
-----------------
Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens

Conditions
-----------------
Refractive Errors

Intervention / Treatment
-----------------
* Device: LID021201 contact lenses
* Device: OPTI-FREE multipurpose solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Understand and sign an Informed Consent that has been approved by an Institutional Review Board. Successful wear of spherical daily wear frequent replacement 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. Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LID021201<br>LID021201 contact lenses worn in both eyes for 7 days. Lenses will be removed nightly for cleaning and disinfection with OPTI-FREE multipurpose solution. | Device: LID021201 contact lenses<br>* Investigational silicone hydrogel sphere contact lenses for frequent replacement daily wear<br>Device: OPTI-FREE multipurpose solution<br>* Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses<br>* Other names: OPTI-FREE® RepleniSH®;|

What is the study measuring?
-----------------
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, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed. | Dispense; Week 1 Follow-up | 

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