AmetropiaNCT06400914
Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere
A study testing Lens A (ocufilcon D) and Lens B (fanfilcon A) in people with Ametropia, run by CooperVision, Inc. at 1 site in Mexico.
Trial summary
The aim of this study is to compare the short-term clinical performance of two sphere contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ametropia
- What is being tested?
- Lens A (ocufilcon D) and Lens B (fanfilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteMexico
- Study dates
- 3 Apr 2024to 11 May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and signed an information consent letter.
- Self-reports having a full eye examination in the previous two years.
- Anticipates being able to wear the study lenses for the required time of the study.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Has refractive astigmatism no higher than -0.75 DC.
- Can be fit with the available lens parameters (sphere +6.00 to -10.00D).
- Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.
Who cannot join
- Is participating in any concurrent clinical or research study.
- Has any known active ocular disease and/or infection that contraindicates contact lens wear.
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
- Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
- Has known sensitivity to the diagnostic sodium fluorescein used in the study.
- Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
- Has undergone refractive error surgery or intraocular surgery.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the short-term clinical performance of two sphere contact lenses.
Read the detailed description
The aim of this study is to evaluate the short-term clinical performance of two different sphere contact lenses after 15 minutes of daily wear each.
- Conditions
- Ametropia
- Being tested
- Lens A (ocufilcon D), Lens B (fanfilcon A)
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens A (ocufilcon D)Device
15 minutes of daily wear.
Lens B (fanfilcon A)Device
15 minutes of daily wear.
| Study group | Role | What they receive |
|---|---|---|
| Lens A (ocufilcon D) | Experimental | All participants will wear lens A for 15 minutes (Period 1). Receives: Device: Lens A (ocufilcon D) |
| Lens B (fanfilcon A) | Experimental | All participants will wear lens B for 15 minutes (Period 2). Receives: Device: Lens B (fanfilcon A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Fit Acceptance Ratings
Overall lens fit acceptance was measured on a scale from 0-4 (0=Should not be worn and 4= Perfect)
Measured: At the end of 15 Minutes of wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start3 Apr 2024
- Primary completion11 May 2024
- Study completion11 May 2024
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 AmetropiaStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Ocular Research & Education, Canada
- Responsible party
- Sponsor
- Investigators
- Ruben Guerrero, MSc, FIACLE, Principal investigator, National Autonomous University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400914
- Sponsor's protocol ID
- EX-MKTG-156
- Status last verified
- Aug 2025
- First submitted
- 24 Apr 2024
- Last updated
- 15 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere
- ClinicalTrials.gov ID
- NCT06400914
- Acronym / sponsor ID
- EX-MKTG-156
- Conditions
- Ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centre for Ocular Research & Education, Canada
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Posted 3 Jul 2025
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 study is to compare the short-term clinical performance of two sphere contact lenses.
Detailed description
The aim of this study is to evaluate the short-term clinical performance of two different sphere contact lenses after 15 minutes of daily wear each.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lens A (ocufilcon D) | Experimental | Device: Lens A (ocufilcon D)All participants will wear lens A for 15 minutes (Period 1). |
| Lens B (fanfilcon A) | Experimental | Device: Lens B (fanfilcon A)All participants will wear lens B for 15 minutes (Period 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and signed an information consent letter.
- Self-reports having a full eye examination in the previous two years.
- Anticipates being able to wear the study lenses for the required time of the study.
- Is willing and able to follow instructions and maintain the appointment schedule.
Key exclusion criteria (7 listed)
- Is participating in any concurrent clinical or research study.
- Has any known active ocular disease and/or infection that contraindicates contact lens wear.
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
- Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
- Has known sensitivity to the diagnostic sodium fluorescein used in the study.
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 |
|---|---|---|
| Lens A (ocufilcon D)15 minutes of daily wear. | Device | Lens A (ocufilcon D) |
| Lens B (fanfilcon A)15 minutes of daily wear. | Device | Lens B (fanfilcon A) |
Primary outcome
Lens Fit Acceptance Ratings
Time frame: At the end of 15 Minutes of wear
Overall lens fit acceptance was measured on a scale from 0-4 (0=Should not be worn and 4= Perfect)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?
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Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial
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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.
Ruben Guerrero, MSc, FIACLE principal investigator
National Autonomous University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lens A (ocufilcon D) and Lens B (fanfilcon A) in people with Ametropia, 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 8 inclusion and 7 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 15 Aug 2025. 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 3 Jul 2025). 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?
Lens Fit Acceptance Ratings (time frame: At the end of 15 Minutes of wear). 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 15 Aug 2025.