Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: 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)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720-2020
      • University of California, Berkeley Clinical Research Center (UCB-CRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Meng Lin, OD PhD FAAO, CRC-UC Berkeley

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 15, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 22, 2013

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-44