Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: Pair 2 (ocufilcon D / enfilcon A)
Device: Pair 6 (omafilcon A / comfilcon A)
Device: Pair 1 (ocufilcon D / ocufilcon D)
Device: Pair 3 (ocufilcon D / comfilcon A)
Device: Pair 4 (methafilcon A / methafilcon A)
Device: Pair 5 (methafilcon A / comfilcon A)

Registration Number: NCT01966770

Lead Sponsor: Coopervision, Inc.

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

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pair 2 (ocufilcon D / enfilcon A)	Pair 2 (ocufilcon D / enfilcon A)	Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
Pair 6 (omafilcon A / comfilcon A)	Pair 6 (omafilcon A / comfilcon A)	Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
Pair 1 (ocufilcon D / ocufilcon D)	Pair 1 (ocufilcon D / ocufilcon D)	Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
Pair 3 (ocufilcon D / comfilcon A)	Pair 3 (ocufilcon D / comfilcon A)	Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
Pair 4 (methafilcon A / methafilcon A)	Pair 4 (methafilcon A / methafilcon A)	Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
Pair 5 (methafilcon A / comfilcon A)	Pair 5 (methafilcon A / comfilcon A)	Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)

Primary Outcome Measures

Name	Time	Method
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)	Day 1 - Insertion	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)
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)	Day 1 - 30 minutes	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)
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)	Day 2 - Insertion	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)
Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens)	Baseline	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)
Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)	Day 2 - 30 minutes	Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens.(Upgaze Lag and Post-blink Movement in mm)
Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses)	Day 2 - 30 minutes	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
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)	Day 1 - 30 minutes	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)
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)	Day 1 - 30 minutes	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)
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)	Day 2 - 30 minutes	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)
Visual Acuity (VA) logMAR (Study Lenses)	Dispense	Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)
Comfort Contact Lens Insertion (Day 1 Study Lenses)	Day 1 - Insertion	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)
Comfort Contact Lens Insertion (Day 2 Study Lenses)	Day 2 - Insertion	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
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)	Day 1 - Insertion	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)
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)	Day 2 - Insertion	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)
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)	Day 2 - Insertion	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)
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)	Day 2 - 30 minutes	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)
Lens Fitting Characteristics, Centration (Day 1 Study Lenses)	Day 1 - 30 minutes	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)
Lens Fitting Characteristics, Centration (Day 2 Study Lenses)	Day 2 - 30 minutes	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)
Visual Acuity (VA) logMAR (Habitual Lenses)	Baseline	Assessment of high contrast distance visual acuity (VA). Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (logMAR)
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)	Day 2 - 30 minutes	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)
Lens Fitting Characteristics, Tightness (Habitual Lens)	Baseline	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)
Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)	Day 1 - 30 minutes	Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. (Upgaze Lag and Post-blink Movement in mm)
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)	Day 2 - Insertion	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)
Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses)	Day 1 - 30 minutes	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)
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)	Day 1 Insertion	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)
Lens Fitting Characteristics, Centration (Habitual Lens)	Baseline	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)
Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses)	Day 1 - 30 minutes	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)
Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses)	Day 2 - 30 minutes	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)
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)	Day 1- 30 minutes	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)
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)	Day 1- 30 minutes	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)
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)	Day 1 - 30 minutes	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)
Overall Ease of Lens Handling (Day 2 Study Lenses)	Day 2 - After Removal	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
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)	Day 2 - Insertion	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)
Overall Ease of Lens Handling (Day 1 Study Lenses)	Day 1 - After Removal	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
Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)	Day 2 - Insertion	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)