MyopiaNCT02727816
Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.
A study testing filcon IV I (BC 8.6), filcon IV I (BC 8.7) and ocufilcon D in people with Myopia, run by CooperVision, Inc. at 1 site in Mexico.
Trial summary
The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- filcon IV I (BC 8.6), filcon IV I (BC 8.7) and ocufilcon D
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2016to Aug 2016
- 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
- Healthy volunteers accepted
- 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 CL (Contact Lens) wearer.
- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- Has a spectacle cylinder up to 0.75D (Diopters) in each eye.
Show all 13Show fewer
- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- Has clear corneas and no active ocular disease.
- Has read, understood and signed the information consent letter.
- Patient contact lens refraction should fit within the available parameters of the study lenses.
- 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 CL wear (5 days per week; > 8 hours/day)
- Has a CL prescription outside the range of - 1.00 to - 6.00D
- Has a spectacle cylinder ≥1.00D of cylinder in either eye.
Show all 23Show fewer
- Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
- Presence of clinically significant (grade 2-4) anterior segment abnormalities.
- Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
- Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GPC) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea.
- Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.
Read the detailed description
This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows:
Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D
Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D
Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D
Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A
- Conditions
- Myopia
- Being tested
- filcon IV I (BC 8.6), filcon IV I (BC 8.7), ocufilcon D, methafilcon A (BC 8.6), methafilcon A (BC 8.7)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filcon IV I (BC 8.6)Device
control lens
filcon IV I (BC 8.7)Device
control lens
ocufilcon DDevice
test lens
methafilcon A (BC 8.6)Device
control lens
methafilcon A (BC 8.7)Device
control lens
somofilcon ADevice
test lens
| Study group | Role | What they receive |
|---|---|---|
| filcon IV I (BC 8.6) / ocufilcon D (pair one) | Experimental | Participants were randomized to a test and control lens for each pair in a contralateral design. Receives: Device: filcon IV I (BC 8.6); Device: ocufilcon D |
| filcon IV I (BC 8.7) / ocufilcon D (pair two) | Experimental | Participants were randomized to a test and control lens for each pair in a contralateral design. Receives: Device: filcon IV I (BC 8.7); Device: ocufilcon D |
| methafilcon A (BC 8.6) / ocufilcon D (pair three) | Experimental | Participants were randomized to a test and control lens for each pair in a contralateral design. Receives: Device: ocufilcon D; Device: methafilcon A (BC 8.6) |
| methafilcon A (BC 8.7) / somofilcon A (pair four) | Experimental | Participants were randomized to a test and control lens for each pair in a contralateral design. Receives: Device: methafilcon A (BC 8.7); Device: somofilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Centration - Pair One
Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Measured: Baseline and 1 hour
Centration - Pair Two
Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Measured: Baseline and 1 hour
Centration - Pair Three
Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Measured: Baseline and 1 hour
Centration - Pair Four
Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Measured: Baseline and 1 hour
Post-blink Movement - Pair One
Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Measured: Baseline
Post-blink Movement - Pair One
Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Measured: 1 hour
Post-blink Movement - Pair Two
Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Measured: Baseline
Post-blink Movement - Pair Two
Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Measured: 1 hour
Post-blink Movement - Pair Three
Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Measured: Baseline
Post-blink Movement - Pair Three
Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Measured: 1 hour
Post-blink Movement - Pair Four
Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Measured: Baseline
Post-blink Movement - Pair Four
Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Measured: 1 hour
Lens Tightness - Pair One
Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Measured: Baseline and 1 hour
Lens Tightness - Pair Two
Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Measured: Baseline and 1 hour
Lens Tightness - Pair Three
Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Measured: Baseline and 1 hour
Lens Tightness - Pair Four
Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Measured: Baseline and 1 hour
Overall Fit Preference - Pair One
Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference.
Measured: Baseline and 1 hour
Overall Fit Acceptance - Pair Two
Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference.
Measured: Baseline and 1 hour
Overall Fit Acceptance - Pair Three
Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference.
Measured: Baseline and 1 hour
Overall Fit Acceptance - Pair Four
Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference.
Measured: Baseline and 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2016
- Study completionAug 2016
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727816
- Sponsor's protocol ID
- EX-MKTG-65
- Status last verified
- Jul 2017
- First submitted
- 30 Mar 2016
- Last updated
- 6 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.
- ClinicalTrials.gov ID
- NCT02727816
- Acronym / sponsor ID
- EX-MKTG-65
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Posted 6 Feb 2018
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 non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.
Detailed description
This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows:
Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D
Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D
Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D
Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| filcon IV I (BC 8.6) / ocufilcon D (pair one) | Experimental | Device: filcon IV I (BC 8.6), Device: ocufilcon DParticipants were randomized to a test and control lens for each pair in a contralateral design. |
| filcon IV I (BC 8.7) / ocufilcon D (pair two) | Experimental | Device: filcon IV I (BC 8.7), Device: ocufilcon DParticipants were randomized to a test and control lens for each pair in a contralateral design. |
| methafilcon A (BC 8.6) / ocufilcon D (pair three) | Experimental | Device: ocufilcon D, Device: methafilcon A (BC 8.6)Participants were randomized to a test and control lens for each pair in a contralateral design. |
| methafilcon A (BC 8.7) / somofilcon A (pair four) | Experimental | Device: methafilcon A (BC 8.7), Device: somofilcon AParticipants were randomized to a test and control lens for each pair in a contralateral design. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 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 CL (Contact Lens) wearer.
- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- Has a spectacle cylinder up to 0.75D (Diopters) in each eye.
Key exclusion criteria (23 listed)
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has a CL 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 |
|---|---|---|
| filcon IV I (BC 8.6)control lens | Device | filcon IV I (BC 8.6) / ocufilcon D (pair one) |
| filcon IV I (BC 8.7)control lens | Device | filcon IV I (BC 8.7) / ocufilcon D (pair two) |
| ocufilcon Dtest lens | Device | filcon IV I (BC 8.6) / ocufilcon D (pair one), filcon IV I (BC 8.7) / ocufilcon D (pair two), methafilcon A (BC 8.6) / ocufilcon D (pair three) |
| methafilcon A (BC 8.6)control lens | Device | methafilcon A (BC 8.6) / ocufilcon D (pair three) |
| methafilcon A (BC 8.7)control lens | Device | methafilcon A (BC 8.7) / somofilcon A (pair four) |
| somofilcon Atest lens | Device | methafilcon A (BC 8.7) / somofilcon A (pair four) |
Primary outcome
Centration - Pair One
Time frame: Baseline and 1 hour
Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Centration - Pair Two
Time frame: Baseline and 1 hour
Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Centration - Pair Three
Time frame: Baseline and 1 hour
Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Centration - Pair Four
Time frame: Baseline and 1 hour
Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Post-blink Movement - Pair One
Time frame: Baseline
Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair One
Time frame: 1 hour
Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Two
Time frame: Baseline
Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Two
Time frame: 1 hour
Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Three
Time frame: Baseline
Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Three
Time frame: 1 hour
Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Four
Time frame: Baseline
Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Four
Time frame: 1 hour
Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Lens Tightness - Pair One
Time frame: Baseline and 1 hour
Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Lens Tightness - Pair Two
Time frame: Baseline and 1 hour
Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Lens Tightness - Pair Three
Time frame: Baseline and 1 hour
Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Lens Tightness - Pair Four
Time frame: Baseline and 1 hour
Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Overall Fit Preference - Pair One
Time frame: Baseline and 1 hour
Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference.
Overall Fit Acceptance - Pair Two
Time frame: Baseline and 1 hour
Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference.
Overall Fit Acceptance - Pair Three
Time frame: Baseline and 1 hour
Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference.
Overall Fit Acceptance - Pair Four
Time frame: Baseline and 1 hour
Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing filcon IV I (BC 8.6), filcon IV I (BC 8.7) and ocufilcon D in people with Myopia, run by CooperVision, Inc. at 1 site in Mexico.
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 13 inclusion and 23 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 6 Feb 2018. 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 Mexico. 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 6 Feb 2018). 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?
Centration - Pair One (time frame: Baseline and 1 hour). The study lists 20 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 6 Feb 2018.