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Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pair 1 (ocufilcon D / ocufilcon D)
Pair 2 (ocufilcon D / enfilcon A)
Pair 3 (ocufilcon D / comfilcon A)
Pair 4 (methafilcon A / methafilcon A)
Pair 5 (methafilcon A / comfilcon A)
Pair 6 (omafilcon A / comfilcon A)
Sponsored by
Coopervision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Berkeley Clinical Research Center (UCB-CRC)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Pair 1 (ocufilcon D / ocufilcon D)

Pair 2 (ocufilcon D / enfilcon A)

Pair 3 (ocufilcon D / comfilcon A)

Pair 4 (methafilcon A / methafilcon A)

Pair 5 (methafilcon A / comfilcon A)

Pair 6 (omafilcon A / comfilcon A)

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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)
Visual Acuity (VA) logMAR (Study Lenses)
Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)
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)
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)
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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

Secondary Outcome Measures

Full Information

First Posted
October 15, 2013
Last Updated
July 19, 2020
Sponsor
Coopervision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01966770
Brief Title
Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses
Official Title
Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pair 1 (ocufilcon D / ocufilcon D)
Arm Type
Active Comparator
Arm Description
Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
Arm Title
Pair 2 (ocufilcon D / enfilcon A)
Arm Type
Active Comparator
Arm Description
Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
Arm Title
Pair 3 (ocufilcon D / comfilcon A)
Arm Type
Active Comparator
Arm Description
Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
Arm Title
Pair 4 (methafilcon A / methafilcon A)
Arm Type
Active Comparator
Arm Description
Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
Arm Title
Pair 5 (methafilcon A / comfilcon A)
Arm Type
Active Comparator
Arm Description
Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
Arm Title
Pair 6 (omafilcon A / comfilcon A)
Arm Type
Active Comparator
Arm Description
Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
Intervention Type
Device
Intervention Name(s)
Pair 1 (ocufilcon D / ocufilcon D)
Intervention Description
Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
Intervention Type
Device
Intervention Name(s)
Pair 2 (ocufilcon D / enfilcon A)
Intervention Description
Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
Intervention Type
Device
Intervention Name(s)
Pair 3 (ocufilcon D / comfilcon A)
Intervention Description
Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
Intervention Type
Device
Intervention Name(s)
Pair 4 (methafilcon A / methafilcon A)
Intervention Description
Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
Intervention Type
Device
Intervention Name(s)
Pair 5 (methafilcon A / comfilcon A)
Intervention Description
Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
Intervention Type
Device
Intervention Name(s)
Pair 6 (omafilcon A / comfilcon A)
Intervention Description
Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
Primary Outcome Measure Information:
Title
Visual Acuity (VA) logMAR (Habitual Lenses)
Description
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
Title
Visual Acuity (VA) logMAR (Study Lenses)
Description
Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)
Time Frame
Dispense
Title
Comfort Contact Lens Insertion (Day 1 Study Lenses)
Description
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
Title
Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses)
Description
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
Title
Comfort Contact Lens Insertion (Day 2 Study Lenses)
Description
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
Title
Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses)
Description
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
Title
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)
Description
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 1 - Insertion
Title
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)
Description
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
Title
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)
Description
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
Title
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
Description
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
Title
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
Description
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
Title
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
Description
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
Title
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)
Description
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
Title
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)
Description
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
Title
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)
Description
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
Title
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
Description
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
Title
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
Description
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
Title
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
Description
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
Title
Lens Fitting Characteristics, Centration (Habitual Lens)
Description
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
Title
Lens Fitting Characteristics, Tightness (Habitual Lens)
Description
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
Title
Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens)
Description
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
Title
Lens Fitting Characteristics, Centration (Day 1 Study Lenses)
Description
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
Title
Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses)
Description
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
Title
Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)
Description
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
Title
Lens Fitting Characteristics, Centration (Day 2 Study Lenses)
Description
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
Title
Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses)
Description
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
Title
Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)
Description
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
Title
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
Description
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
Title
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
Description
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
Title
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
Description
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
Title
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
Description
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
Title
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
Description
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
Title
Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
Description
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
Title
Overall Ease of Lens Handling (Day 1 Study Lenses)
Description
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
Title
Overall Ease of Lens Handling (Day 2 Study Lenses)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng Lin, OD PhD FAAO
Organizational Affiliation
CRC-UC Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Berkeley Clinical Research Center (UCB-CRC)
City
Berkeley
State/Province
California
ZIP/Postal Code
94720-2020
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses

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