Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses

Study Overview
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Brief Summary
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The aim of this fitting study is to evaluate the clinical performance of different hydrogel and silicone hydrogel contact lenses.

Detailed Description
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This is a 20-subject, double masked, randomized, contra lateral, 2-day non-dispensing fitting trial.

Official Title
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Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Pair 1 (ocufilcon D / ocufilcon D)
* Device: Pair 2 (ocufilcon D / enfilcon A)
* Device: Pair 3 (ocufilcon D / comfilcon A)
* Device: Pair 4 (methafilcon A / methafilcon A)
* Device: Pair 5 (methafilcon A / comfilcon A)
* Device: Pair 6 (omafilcon A / comfilcon 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 contact lens wearer Has a cl spherical prescription between -1.00 and -6.00 (inclusive) Has a spectacle cylinder up to 0.75D (diopter) in each eye Is correctable to a visual acuity of 20/25 or better in both eyes Has clear corneas and no active ocular disease Has read, understood and signed the information consent letter 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 contact lens wear (5 days per week; > 8 hours/day) Has a contact lens prescription outside the range of -1.00 to -6.00D Has a spectacle cylinder ≥ 1.00D of cylinder in either eye Has best corrected spectacle distance vision worse than 20/25 in either eye Has any systemic or topical medications that will affect ocular health Has any ocular pathology or severe insufficiency of lacrimal secretion Has persistent, clinically significant corneal or conjunctival staining Has active neovascularization or any central corneal scars Is aphakic Is presbyopic Has undergone corneal refractive surgery Is participating in any other type of eye related conical 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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pair 1 (ocufilcon D / ocufilcon D)<br>Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel) | Device: Pair 1 (ocufilcon D / ocufilcon D)<br>* Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)<br>|
| Active Comparator: Pair 2 (ocufilcon D / enfilcon A)<br>Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone) | Device: Pair 2 (ocufilcon D / enfilcon A)<br>* Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)<br>|
| Active Comparator: Pair 3 (ocufilcon D / comfilcon A)<br>Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone) | Device: Pair 3 (ocufilcon D / comfilcon A)<br>* Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)<br>|
| Active Comparator: Pair 4 (methafilcon A / methafilcon A)<br>Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere) | Device: Pair 4 (methafilcon A / methafilcon A)<br>* Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)<br>|
| Active Comparator: Pair 5 (methafilcon A / comfilcon A)<br>Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone) | Device: Pair 5 (methafilcon A / comfilcon A)<br>* Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)<br>|
| Active Comparator: Pair 6 (omafilcon A / comfilcon A)<br>Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone) | Device: Pair 6 (omafilcon A / comfilcon A)<br>* Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity (VA) logMAR (Habitual Lenses) | Assessment of high contrast distance visual acuity (VA). Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (logMAR) | Baseline | 
| Visual Acuity (VA) logMAR (Study Lenses) | Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR) | Dispense | 
| Comfort Contact Lens Insertion (Day 1 Study Lenses) | Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 1 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever) | Day 1 - Insertion | 
| Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses) | Participant rating of comfort after contact lens settling. Collected at 30 minutes wear for each lens. (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever) | Day 1 - 30 minutes | 
| Comfort Contact Lens Insertion (Day 2 Study Lenses) | Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 2 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever | Day 2 - Insertion | 
| Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses) | Participant rating of comfort upon contact lens insertion. Collected after 30 minutes of wear at Day 2 for each lens . (0-100, 0=cannot be be worn causes pain, 100=cannot be felt ever | Day 2 - 30 minutes | 
| Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1) | Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) | Day 1 - Insertion | 
| Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2) | Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) | Day 1 Insertion | 
| Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3) | Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) | Day 1 - Insertion | 
| Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1) | Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) | Day 1 - 30 minutes | 
| Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2) | Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) | Day 1 - 30 minutes | 
| Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3) | Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) | Day 1 - 30 minutes | 
| Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1) | Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) | Day 2 - Insertion | 
| Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2) | Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) | Day 2 - Insertion | 
| Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3) | Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) | Day 2 - Insertion | 
| Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1) | Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right) | Day 2 - 30 minutes | 
| Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2) | Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right) | Day 2 - 30 minutes | 
| Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3) | Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right) | Day 2 - 30 minutes | 
| Lens Fitting Characteristics, Centration (Habitual Lens) | Assessment of habitual lens fitting characteristics for the percentage of lenses with optimal centration. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable) | Baseline | 
| Lens Fitting Characteristics, Tightness (Habitual Lens) | Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement) | Baseline | 
| Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens) | Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens.(Upgaze Lag and Post-blink Movement in mm) | Baseline | 
| Lens Fitting Characteristics, Centration (Day 1 Study Lenses) | Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable) | Day 1 - 30 minutes | 
| Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses) | Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement) | Day 1 - 30 minutes | 
| Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses) | Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. (Upgaze Lag and Post-blink Movement in mm) | Day 1 - 30 minutes | 
| Lens Fitting Characteristics, Centration (Day 2 Study Lenses) | Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable) | Day 2 - 30 minutes | 
| Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses) | Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement) | Day 2 - 30 minutes | 
| Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses) | Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens.(Upgaze Lag and Post-blink Movement in mm) | Day 2 - 30 minutes | 
| Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1) | Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L) | Day 1- 30 minutes | 
| Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2) | Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L) | Day 1- 30 minutes | 
| Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3) | Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L) | Day 1 - 30 minutes | 
| Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1) | Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L) | Day 2 - Insertion | 
| Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2) | Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L) | Day 2 - Insertion | 
| Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3) | Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L) | Day 2 - Insertion | 
| Overall Ease of Lens Handling (Day 1 Study Lenses) | Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 1. (0-100, 0=very difficult, 100=very easy | Day 1 - After Removal | 
| Overall Ease of Lens Handling (Day 2 Study Lenses) | Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 2. (0-100, 0=very difficult, 100=very easy | Day 2 - After Removal |