Apioc Toric/Spherical Single Vision Contact Lens

Study Overview
=================
Brief Summary
-----------------
The Lentechs Apioc-S and Apioc-A contact lenses are made in an FDA-approved contact lens material indicated for single-vision and astigmatism. The novel lens design has a lenticular portion which is thicker than the optical portion of the lens. When applied to the eye, it is oriented in a superior position. Unlike contact lenses currently on the market, this innovative design improves lens stability by preventing lens rotation, and may improve tear flow behind the lens.

Official Title
-----------------
30 Day Fitting of a New Toric Contact Lens

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

Intervention / Treatment
-----------------
* Device: Apioc-A and Apioc-S Contact Lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must provide written informed consent. The subject must appear willing and able to adhere to the instructions set forth in this protocol. At least 18 years of age and no more than 35 years of age. ≤ 4.00 D of corneal astigmatism. ≤ 4.00 D of refractive astigmatism. Refractive error range +20.00 DS to -20.00 DS Flat and steep keratometry readings within 40 to 50D. Clear, healthy corneas with no irregular astigmatism. Normal, healthy conjunctiva in both eyes. Free of active ocular disease. Refractive error is permitted. Be a current or former (within the last 12 months) contact lens wearer. Best-corrected near and distance visual acuity better than or equal to 20/25. Exclusion Criteria: Irregular corneal astigmatism. Presbyopia Corneal scarring unless off line-of-site and well healed. Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear. Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Use of artificial tears less than 3 drops per week is permitted. Systemic disease that would interfere with contact lens wear. Currently pregnant or lactating (by self-report). History of strabismus or eye movement disorder. Active allergies that may inhibit contact lens wear. Upper eyelid margin at or above the superior limbus. History of ocular or lid surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Apioc-A and Apioc-S Contact Lenses|Appropriately fit, document and dispense a new spherical and toric contact lens design worn for up to 35 days.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | LogMAR distance visual acuity | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Contact Lens Dry Eye Questionnaire-8, scale range 0 minimum (better outcome) to 38 maximum (worse outcome). | 30 days | 
| Rotational Stability of Apioc-A | Clockwise or counter-clockwise rotation | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contact lens, soft contact lens