Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.

Study Overview
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Brief Summary
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The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.

Detailed Description
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This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows: Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A

Official Title
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Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.

Conditions
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Myopia

Intervention / Treatment
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* Device: filcon IV I (BC 8.6)
* Device: filcon IV I (BC 8.7)
* Device: ocufilcon D
* Device: methafilcon A (BC 8.6)
* Device: methafilcon A (BC 8.7)
* Device: somofilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Is between 18 and 40 years of age (inclusive). Has had a self-reported visual exam in the last two years. Is an adapted soft CL (Contact Lens) wearer. Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive) Has a spectacle cylinder up to 0.75D (Diopters) in each eye. Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. Has clear corneas and no active ocular disease. Has read, understood and signed the information consent letter. Patient contact lens refraction should fit within the available parameters of the study lenses. Is willing to comply with the wear schedule. Is willing to comply with the visit schedule. Exclusion Criteria: A person will be excluded from the study if he/she: Has never worn contact lenses before. Currently wears rigid gas permeable contact lenses. Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day) Has a CL prescription outside the range of - 1.00 to - 6.00D Has a spectacle cylinder ≥1.00D of cylinder in either eye. Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. Presence of clinically significant (grade 2-4) anterior segment abnormalities. Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. Slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Pterygium, pinguecula, or corneal scars within the visual axis Neovascularization > 0.75 mm in from of the limbus Giant papillary conjunctivitis (GPC) worse than grade 1 Anterior uveitis or iritis (past or present) Seborrheic eczema, Seborrheic conjunctivitis History of corneal ulcers or fungal infections Poor personal hygiene Has a known history of corneal hypoesthesia (reduced corneal sensitivity) Has aphakia, keratoconus or a highly irregular cornea. Has Presbyopia or has dependence on spectacles for near work over the contact lenses. Has undergone corneal refractive surgery. Is participating in any other type of eye related clinical or research study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: filcon IV I (BC 8.6) / ocufilcon D (pair one)<br>Participants were randomized to a test and control lens for each pair in a contralateral design. | Device: filcon IV I (BC 8.6)<br>* control lens<br>Device: ocufilcon D<br>* test lens<br>|
| Experimental: filcon IV I (BC 8.7) / ocufilcon D (pair two)<br>Participants were randomized to a test and control lens for each pair in a contralateral design. | Device: filcon IV I (BC 8.7)<br>* control lens<br>Device: ocufilcon D<br>* test lens<br>|
| Experimental: methafilcon A (BC 8.6) / ocufilcon D (pair three)<br>Participants were randomized to a test and control lens for each pair in a contralateral design. | Device: ocufilcon D<br>* test lens<br>Device: methafilcon A (BC 8.6)<br>* control lens<br>|
| Experimental: methafilcon A (BC 8.7) / somofilcon A (pair four)<br>Participants were randomized to a test and control lens for each pair in a contralateral design. | Device: methafilcon A (BC 8.7)<br>* control lens<br>Device: somofilcon A<br>* test lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Centration - Pair One | Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable). | Baseline and 1 hour | 
| Centration - Pair Two | Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable). | Baseline and 1 hour | 
| Centration - Pair Three | Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable). | Baseline and 1 hour | 
| Centration - Pair Four | Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable). | Baseline and 1 hour | 
| Post-blink Movement - Pair One | Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Baseline | 
| Post-blink Movement - Pair One | Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | 1 hour | 
| Post-blink Movement - Pair Two | Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Baseline | 
| Post-blink Movement - Pair Two | Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | 1 hour | 
| Post-blink Movement - Pair Three | Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Baseline | 
| Post-blink Movement - Pair Three | Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | 1 hour | 
| Post-blink Movement - Pair Four | Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | Baseline | 
| Post-blink Movement - Pair Four | Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement). | 1 hour | 
| Lens Tightness - Pair One | Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support) | Baseline and 1 hour | 
| Lens Tightness - Pair Two | Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support) | Baseline and 1 hour | 
| Lens Tightness - Pair Three | Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support) | Baseline and 1 hour | 
| Lens Tightness - Pair Four | Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support) | Baseline and 1 hour | 
| Overall Fit Preference - Pair One | Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference. | Baseline and 1 hour | 
| Overall Fit Acceptance - Pair Two | Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference. | Baseline and 1 hour | 
| Overall Fit Acceptance - Pair Three | Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference. | Baseline and 1 hour | 
| Overall Fit Acceptance - Pair Four | Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference. | Baseline and 1 hour |