Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.

Detailed Description
-----------------
Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.

Official Title
-----------------
Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses

Conditions
-----------------
Myopia, Astigmatism

Intervention / Treatment
-----------------
* Device: comfilcon A MTO
* Device: comfilcon A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has had a self-reported oculo-visual examination in the last two years. Is at least 18 years of age and has full legal capacity to volunteer. Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. Currently wears soft contact lenses. Has clear corneas and no active ocular disease. Has not worn lenses for at least 12 hours before the examination Exclusion Criteria: Has never worn contact lenses before. Has any systemic disease affecting ocular health. Is using any systemic or topical medications that will affect ocular health. Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. Is aphakic. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: comfilcon A MTO<br>Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. | Device: comfilcon A<br>* Randomized to a test lens in one eye and control lens in the other as a matched pair.<br>* Other names: Biofinity Toric;|
| Active Comparator: comfilcon A<br>Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. | Device: comfilcon A MTO<br>* Randomized to a test lens in one eye and control lens in the other as a matched pair.<br>* Other names: Biofinity Toric MTO;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Surface Assessment of Study Lenses - Surface Wettability | Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent) | 15min & 6hrs | 
| Lens Surface Assessment of Study Lenses - Deposits | Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film > 75% of surface) | 15min & 6hrs | 
| Lens Surface Assessment of Study Lenses - Surface Acceptance | Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent) | 15min & 6hrs | 
| Subjective Rating For Comfort - Comfort Since Last Visit | Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever) | 15min, 3hrs, 6hrs | 
| Subjective Rating For Comfort Preference | Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens) | 1min, 15min, 3hrs, 6hrs | 
| Subjective Rating For Handling - Insertion | Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye) | 1 min | 
| Subjective Rating For Handling - Removal | Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye) | 1 min | 
| Investigator's Assessment of Stability | Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability. | 15min & 6hrs | 
| General Lens Fit - Fit Acceptance | Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect) | 15min & 6hrs | 
| Lens Fitting - Rotation/Mislocation | Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-). | Baseline, 15min & 6hrs | 
| Anterior Ocular Health - Corneal Staining (Central) | Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | baseline & 6hrs | 
| Anterior Ocular Health - Corneal Staining (Nasal) | Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | baseline & 6hrs | 
| Anterior Ocular Health - Corneal Staining (Temporal) | Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | baseline & 6hrs | 
| Anterior Ocular Health - CornealStaining (Superior) | Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | baseline & 6hrs | 
| Anterior Ocular Health - Corneal Staining (Inferior) | Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area) | baseline & 6hrs | 
| Anterior Ocular Health - Conjunctival Staining (Nasal) | Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent). | baseline & 6hrs | 
| Anterior Ocular Health - Conjunctival Staining (Superior) | Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent). | baseline & 6hrs | 
| Anterior Ocular Health - Conjunctival Staining (Temporal) | Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent). | baseline & 6hrs | 
| Anterior Ocular Health - Conjunctival Staining (Inferior) | Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent). | baseline & 6hrs |