AstigmatismNCT05097144
Performance of Toric Silicone Hydrogel Contact Lenses
A study testing Lens A (fanfilcon A) and Lens B (asmofilcon A) in people with Astigmatism and Myopia, run by CooperVision, Inc. at 1 site in Mexico.
Trial summary
The purpose of this study was to evaluate the clinical performance and subjective lens handling (insertion and removal) of two toric silicone hydrogel contact lenses after one month of daily wear each. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Astigmatism, Myopia
- What is being tested?
- Lens A (fanfilcon A) and Lens B (asmofilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 21 Aug 2021to 8 Dec 2021
- 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
- Is not a habitual wearer of either study lens
- Has a contact lens spherical prescription between +4.00 to - 10.00 (inclusive). Best corrected visual acuity of 20/30 or better in either eye
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- Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
- 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 (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
- A person will be excluded from the study if he/she:
- A person was excluded from the study if he/she:
- 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 -2.50 D of cylinder in either eye.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
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- 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 (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: Performance of Two Toric Silicone Hydrogel Contact Lenses
The purpose of this study was to evaluate the clinical performance and subjective lens handling (insertion and removal) of two toric silicone hydrogel contact lenses after one month of daily wear each.
Read the detailed description
This was a prospective, randomized, double masked, bilateral, crossover study. Participants were expected to attend 6 scheduled visits over a period of approximately 2 months.
- Conditions
- Astigmatism, Myopia
- Being tested
- Lens A (fanfilcon A), Lens B (asmofilcon A)
- Medical subject headings
- Astigmatism, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens A (fanfilcon A)Device
Daily wear for one month
Lens B (asmofilcon A)Device
Daily wear for one month
| Study group | Role | What they receive |
|---|---|---|
| Lens A, then Lens B | Experimental | Participants wore Lens A for one month and then wore Lens B for one month. Receives: Device: Lens A (fanfilcon A); Device: Lens B (asmofilcon A) |
| Lens B, then Lens A | Experimental | Participants wore Lens B for one month and then wore Lens A for one month. Receives: Device: Lens A (fanfilcon A); Device: Lens B (asmofilcon A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Handling (Insertion and Removal)
Subjective lens handling measured ease of insertion and removal on a scale of 0-10, where 10=better performance.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start21 Aug 2021
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rubén Velázquez Guerrero, MSc, FIACLE, Principal investigator, National Autonomous University (UNAM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097144
- Sponsor's protocol ID
- EX-MKTG-128
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2021
- Last updated
- 17 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Two Toric Silicone Hydrogel Contact Lenses
- ClinicalTrials.gov ID
- NCT05097144
- Acronym / sponsor ID
- EX-MKTG-128
- Conditions
- Astigmatism, Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Posted 24 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the clinical performance and subjective lens handling (insertion and removal) of two toric silicone hydrogel contact lenses after one month of daily wear each.
Detailed description
This was a prospective, randomized, double masked, bilateral, crossover study. Participants were expected to attend 6 scheduled visits over a period of approximately 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lens A, then Lens B | Experimental | Device: Lens A (fanfilcon A), Device: Lens B (asmofilcon A)Participants wore Lens A for one month and then wore Lens B for one month. |
| Lens B, then Lens A | Experimental | Device: Lens A (fanfilcon A), Device: Lens B (asmofilcon A)Participants wore Lens B for one month and then wore Lens A for one month. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 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 +4.00 to - 10.00 (inclusive). Best corrected visual acuity of 20/30 or better in either eye
Key exclusion criteria (22 listed)
- A person was excluded from the study if he/she:
- 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 -2.50 D of cylinder in either eye.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) 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 |
|---|---|---|
| Lens A (fanfilcon A)Daily wear for one month | Device | Lens A, then Lens B, Lens B, then Lens A |
| Lens B (asmofilcon A)Daily wear for one month | Device | Lens A, then Lens B, Lens B, then Lens A |
Primary outcome
Lens Handling (Insertion and Removal)
Time frame: 1 month
Subjective lens handling measured ease of insertion and removal on a scale of 0-10, where 10=better performance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- 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.
Rubén Velázquez Guerrero, MSc, FIACLE principal investigator
National Autonomous University (UNAM)
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 (fanfilcon A) and Lens B (asmofilcon A) in people with Astigmatism and 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 14 inclusion and 22 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 17 Oct 2023. 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 24 Aug 2022). 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 Handling (Insertion and Removal) (time frame: 1 month). 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 17 Oct 2023.