MyopiaNCT02956460
Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses
A study testing fanfilcon A and senofilcon A in people with Myopia, run by CooperVision, Inc. at 4 sites in United States.
Trial summary
Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair) 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?
- fanfilcon A and senofilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Oct 2016to 14 Dec 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 read, understood and signed the information consent letter
- Has had a self-reported eye exam in the last two years
- Is a spherical soft contact lens wearer
- Has a contact lens prescription that fits within the available parameters of the study lenses
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- Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye
- 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
- Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear)
- Is willing and able to follow instructions and maintain the appointment schedule
Who cannot join
- A person will be excluded from the study if he/she:
- Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days per week; >8 hours/day)
- Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses
- Is habitually using rewetting/ lubricating eye drops more than once per day
- Presents with clinically significant anterior segment abnormalities
- Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
Show all 19Show fewer
- Presents with slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Significant pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (or history in past year)
- Seborrheic eczema of eyelid region, 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kannarr Eye Care
Pittsburg, Kansas, 66762
Eric M. White O. D., Inc
San Diego, California, 92123
Golden Vision
Sarasota, Florida, 34232
Nittany Eye Associates
State College, Pennsylvania, 16801
About this study
Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)
Read the detailed description
The aim of this study is to determine the clinical performance of fanfilcon A in comparison to senofilcon A sphere contact lenses.
- Conditions
- Myopia
- Being tested
- fanfilcon A, senofilcon A
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fanfilcon ADevice
contact lens
senofilcon ADevice
contact lens
| Study group | Role | What they receive |
|---|---|---|
| fanfilcon A | Active comparator | Participants are randomized to wear fanfilcon A for two weeks during the cross over study. Receives: Device: fanfilcon A |
| senofilcon A | Active comparator | Participants are randomized to wear senofilcon A for two weeks during the cross over study. Receives: Device: senofilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Comfort
Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel
Measured: 2 weeks
Overall Dryness
Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness
Measured: 2 weeks
Vision Quality
Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear
Measured: 2 weeks
Lens Handling
Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle
Measured: 2 weeks
Vision Satisfaction
Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Measured: 2 weeks
Lens Centration
Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).
Measured: 2 weeks
Conjunctival Staining
Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification.
0=None, no staining present
- Very slight
- Slight
- Moderate
- Severe
Measured: 2 weeks
Smoothness
Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth
Measured: 2 weeks
Clean Feeling
Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean
Measured: 2 weeks
Lens Hydrated
Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated
Measured: 2 weeks
Lens Wettability
Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start27 Oct 2016
- Primary completion14 Dec 2016
- Study completion14 Dec 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD, FAAO, Study director, Centre for Contact Lens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956460
- Sponsor's protocol ID
- EX-MKTG-73
- Status last verified
- Mar 2018
- First submitted
- 3 Nov 2016
- Last updated
- 2 Apr 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 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses
- ClinicalTrials.gov ID
- NCT02956460
- Acronym / sponsor ID
- EX-MKTG-73
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2016 (actual)
- Primary completion
- 14 Dec 2016 (actual)
- Study completion
- 14 Dec 2016 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Posted 8 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)
Detailed description
The aim of this study is to determine the clinical performance of fanfilcon A in comparison to senofilcon A sphere contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fanfilcon A | Active comparator | Device: fanfilcon AParticipants are randomized to wear fanfilcon A for two weeks during the cross over study. |
| senofilcon A | Active comparator | Device: senofilcon AParticipants are randomized to wear senofilcon A for two weeks during the cross over study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Is between 18 and 40 years of age (inclusive)
- Has read, understood and signed the information consent letter
- Has had a self-reported eye exam in the last two years
- Is a spherical soft contact lens wearer
- Has a contact lens prescription that fits within the available parameters of the study lenses
Key exclusion criteria (19 listed)
- Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days per week; >8 hours/day)
- Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses
- Is habitually using rewetting/ lubricating eye drops more than once per day
- Presents with clinically significant anterior segment abnormalities
- Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
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 |
|---|---|---|
| fanfilcon Acontact lens | Device | fanfilcon A |
| senofilcon Acontact lens | Device | senofilcon A |
Primary outcome
Overall Comfort
Time frame: 2 weeks
Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel
Overall Dryness
Time frame: 2 weeks
Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness
Vision Quality
Time frame: 2 weeks
Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear
Lens Handling
Time frame: 2 weeks
Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle
Vision Satisfaction
Time frame: 2 weeks
Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Lens Centration
Time frame: 2 weeks
Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).
Conjunctival Staining
Time frame: 2 weeks
Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification. 0=None, no staining present 1. Very slight 2. Slight 3. Moderate 4. Severe
Smoothness
Time frame: 2 weeks
Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth
Clean Feeling
Time frame: 2 weeks
Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean
Lens Hydrated
Time frame: 2 weeks
Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated
Lens Wettability
Time frame: 2 weeks
Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 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.
Lyndon Jones, PhD, FAAO study director
Centre for Contact Lens Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fanfilcon A and senofilcon A in people with Myopia, run by CooperVision, Inc. at 4 sites 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 12 inclusion and 19 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 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 8 Dec 2017). 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?
Overall Comfort (time frame: 2 weeks). The study lists 11 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 2 Apr 2018.