MyopiaNCT01966770
Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses
A study testing Pair 1 (ocufilcon D / ocufilcon D), Pair 2 (ocufilcon D / enfilcon A) and Pair 3 (ocufilcon D / comfilcon A) in people with Myopia, run by CooperVision, Inc. at 1 site in United States.
Trial summary
The aim of this fitting study is to evaluate the clinical performance of different hydrogel and silicone hydrogel contact lenses. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- Pair 1 (ocufilcon D / ocufilcon D), Pair 2 (ocufilcon D / enfilcon A) and Pair 3 (ocufilcon D / comfilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley Clinical Research Center (UCB-CRC)
Berkeley, California, 94720-2020
About this study
The aim of this fitting study is to evaluate the clinical performance of different hydrogel and silicone hydrogel contact lenses.
Read the detailed description
This is a 20-subject, double masked, randomized, contra lateral, 2-day non-dispensing fitting trial.
- Conditions
- Myopia
- Being tested
- 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)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pair 1 (ocufilcon D / ocufilcon D)Device
Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
Pair 2 (ocufilcon D / enfilcon A)Device
Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
Pair 3 (ocufilcon D / comfilcon A)Device
Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
Pair 4 (methafilcon A / methafilcon A)Device
Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
Pair 5 (methafilcon A / comfilcon A)Device
Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
Pair 6 (omafilcon A / comfilcon A)Device
Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
| Study group | Role | What they receive |
|---|---|---|
| Pair 1 (ocufilcon D / ocufilcon D) | Active comparator | Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel) Receives: Device: Pair 1 (ocufilcon D / ocufilcon D) |
| Pair 2 (ocufilcon D / enfilcon A) | Active comparator | Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone) Receives: Device: Pair 2 (ocufilcon D / enfilcon A) |
| Pair 3 (ocufilcon D / comfilcon A) | Active comparator | Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone) Receives: Device: Pair 3 (ocufilcon D / comfilcon A) |
| Pair 4 (methafilcon A / methafilcon A) | Active comparator | Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere) Receives: Device: Pair 4 (methafilcon A / methafilcon A) |
| Pair 5 (methafilcon A / comfilcon A) | Active comparator | Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone) Receives: Device: Pair 5 (methafilcon A / comfilcon A) |
| Pair 6 (omafilcon A / comfilcon A) | Active comparator | Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone) Receives: Device: Pair 6 (omafilcon A / comfilcon A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Visual Acuity (VA) logMAR (Study Lenses)
Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Day 2 - After Removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meng Lin, OD PhD FAAO, Principal investigator, CRC-UC Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966770
- Sponsor's protocol ID
- EX-MKTG-44
- Status last verified
- Jul 2020
- First submitted
- 15 Oct 2013
- Last updated
- 30 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses
- ClinicalTrials.gov ID
- NCT01966770
- Acronym / sponsor ID
- EX-MKTG-44
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Posted 27 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pair 1 (ocufilcon D / ocufilcon D) | Active comparator | Device: Pair 1 (ocufilcon D / ocufilcon D)Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel) |
| Pair 2 (ocufilcon D / enfilcon A) | Active comparator | Device: Pair 2 (ocufilcon D / enfilcon A)Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone) |
| Pair 3 (ocufilcon D / comfilcon A) | Active comparator | Device: 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) | Active comparator | Device: 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) | Active comparator | Device: Pair 5 (methafilcon A / comfilcon A)Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone) |
| Pair 6 (omafilcon A / comfilcon A) | Active comparator | Device: Pair 6 (omafilcon A / comfilcon A)Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
Primary outcome
Visual Acuity (VA) logMAR (Habitual Lenses)
Time frame: Baseline
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)
Time frame: Dispense
Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)
Comfort Contact Lens Insertion (Day 1 Study Lenses)
Time frame: 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 30 Minutes Wear (Day 1 Study Lenses)
Time frame: 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 Contact Lens Insertion (Day 2 Study Lenses)
Time frame: 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 Contact Lens 30 Minutes Wear (Day 2 Study Lenses)
Time frame: 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 Insertion (Day 1 Study Lenses - Pair 1)
Time frame: 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 1 Study Lenses - Pair 2)
Time frame: 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)
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)
Time frame: 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 1)
Time frame: 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)
Time frame: 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 1 Study Lenses - Pair 3)
Time frame: 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 1)
Time frame: 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)
Time frame: 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 Insertion (Day 2 Study Lenses - Pair 3)
Time frame: 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)
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
Time frame: 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)
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
Time frame: 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)
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
Time frame: 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)
Lens Fitting Characteristics, Centration (Habitual Lens)
Time frame: 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, Tightness (Habitual Lens)
Time frame: 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, Upgaze Lag and Post-blink Movement (Habitual Lens)
Time frame: 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, Centration (Day 1 Study Lenses)
Time frame: 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, Push-up Tightness (Day 1 Study Lenses)
Time frame: 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, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)
Time frame: 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)
Lens Fitting Characteristics, Centration (Day 2 Study Lenses)
Time frame: 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)
Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses)
Time frame: 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)
Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)
Time frame: 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)
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
Time frame: 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)
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
Time frame: 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)
Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
Time frame: 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)
Overall Ease of Lens Handling (Day 1 Study Lenses)
Time frame: 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
Overall Ease of Lens Handling (Day 2 Study Lenses)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Lin, OD PhD FAAO principal investigator
CRC-UC Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pair 1 (ocufilcon D / ocufilcon D), Pair 2 (ocufilcon D / enfilcon A) and Pair 3 (ocufilcon D / comfilcon A) in people with Myopia, run by CooperVision, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (VA) logMAR (Habitual Lenses) (time frame: Baseline). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.