AstigmatismNCT06490302
Clinical Evaluation of Two Toric Soft Contact Lenses
A study testing Lens A (ocufilcon D) and Lens B (fanfilcon A) in people with Astigmatism, 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 toric contact lenses. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Astigmatism
- 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
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 24 May 2024to 28 Jun 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Is not a habitual wearer of either study lens.
- Has a contact lens spherical prescription between +5.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.
- Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25D in both eyes.
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- 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 informed consent letter.
- Patient contact lens refraction should fit within the available parameters of the study lenses.
- Is willing to comply with the wear schedule (at least 5 days per week, >8 hours/day assuming there are no contraindications for doing so).
- Is willing to comply with the visit schedule.
Who cannot join
- Has a CL prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder less than -0.75D or more than -2.50D of cylinder in either eye.
- 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 form of the limbus
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- Giant papillary conjuctivitis (GCP) 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
Official title: Clinical Evaluation of Biomedics Monthly Toric and Avaira Vitality Toric
The aim of this study is to compare the short-term clinical performance of two toric contact lenses.
Read the detailed description
The aim of this study is to evaluate the short-term clinical performance of two toric contact lenses when compared to each other after 15 minutes of daily wear each.
- Conditions
- Astigmatism
- Being tested
- Lens A (ocufilcon D), Lens B (fanfilcon A)
- Medical subject headings
- Astigmatism
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.
Overall Fit Acceptance
Overall lens fit acceptance was measured on a scale from 0-4 (0= Should not be worn, 4= Perfect)
Measured: At the end of 15 minutes of daily wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start24 May 2024
- Primary completion28 Jun 2024
- Study completion28 Jun 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 AstigmatismStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruben Guerrero, MSc, FIACLE, Principal investigator, National Autonomous University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490302
- Sponsor's protocol ID
- EX-MKTG-157
- Status last verified
- Aug 2025
- First submitted
- 28 Jun 2024
- Last updated
- 22 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Biomedics Monthly Toric and Avaira Vitality Toric
- ClinicalTrials.gov ID
- NCT06490302
- Acronym / sponsor ID
- EX-MKTG-157
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 May 2024 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 8 Jul 2024 (actual)
- Results
- Posted 22 Aug 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 toric contact lenses.
Detailed description
The aim of this study is to evaluate the short-term clinical performance of two toric contact lenses when compared to each other 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 to 40 years
- Sex
- All
- Healthy volunteers
- Not 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 contact lens wearer.
- Is not a habitual wearer of either study lens.
- Has a contact lens spherical prescription between +5.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.
Key exclusion criteria (16 listed)
- Has a CL prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder less than -0.75D or more than -2.50D of cylinder in either eye.
- Slit lamp findings that would contraindicate contact lens wear such as:
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
Overall Fit Acceptance
Time frame: At the end of 15 minutes of daily wear
Overall lens fit acceptance was measured on a scale from 0-4 (0= Should not be worn, 4= Perfect)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- 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.
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 Astigmatism, 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 16 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 22 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 22 Aug 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?
Overall Fit Acceptance (time frame: At the end of 15 minutes of daily 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 22 Aug 2025.