The aim of this fitting study is to evaluate the clinical performance of different hydrogel and silicone hydrogel contact lenses.
This is a 20-subject, double masked, randomized, contra lateral, 2-day non-dispensing fitting trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
University of California, Berkeley Clinical Research Center (UCB-CRC)
Berkeley, California, United States
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)
Time frame: Baseline
Visual Acuity (VA) logMAR (Study Lenses)
Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
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Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Day 2 - After Removal