AmetropiaNCT05516082
Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design
A study testing Lens A and Lens B in people with Ametropia, run by CooperVision, Inc. at 1 site in Mexico.
Trial summary
This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study. 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 and Lens B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteMexico
- Study dates
- 8 Aug 2022to 12 Oct 2022
- 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 +8.00 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
This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.
Read the detailed description
The aim of this study was to evaluate the visual performance and subjective experiences of daily disposable hydrogel lens (DDH) when compared to daily disposable silicone hydrogel lens (DDSH) after 15 minutes of daily wear each.
- Conditions
- Ametropia
- Being tested
- Lens A, Lens B
- 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 ADevice
DDH contact lens for 15 minutes
Lens BDevice
DDSH contact lens for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Lens A | Experimental | All participants wore Lens A for 15 minutes (Period 1) Receives: Device: Lens A |
| Lens B | Experimental | All participants wore Lens B for 15 minutes (Period 2) Receives: Device: Lens B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Fit Acceptance
Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect) as assessed by an investigator.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start8 Aug 2022
- Primary completion12 Oct 2022
- Study completion12 Oct 2022
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
- Model description
- All participants received Lens A and then Lens B in fixed-sequence order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rubén V Guerrero, MSc., FIACLE, Principal investigator, Dr. Ruben Velazquez Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516082
- Sponsor's protocol ID
- EX-MKTG-141
- Status last verified
- Oct 2022
- First submitted
- 23 Aug 2022
- Last updated
- 28 Nov 2023
- 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 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design
- ClinicalTrials.gov ID
- NCT05516082
- Acronym / sponsor ID
- EX-MKTG-141
- Conditions
- Ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Posted 28 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.
Detailed description
The aim of this study was to evaluate the visual performance and subjective experiences of daily disposable hydrogel lens (DDH) when compared to daily disposable silicone hydrogel lens (DDSH) 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
- Model description
- All participants received Lens A and then Lens B in fixed-sequence order.
| Arm | Type | Receives |
|---|---|---|
| Lens A | Experimental | Device: Lens AAll participants wore Lens A for 15 minutes (Period 1) |
| Lens B | Experimental | Device: Lens BAll participants wore 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 ADDH contact lens for 15 minutes | Device | Lens A |
| Lens BDDSH contact lens for 15 minutes | Device | Lens B |
Primary outcome
Lens Fit Acceptance
Time frame: 15 minutes
Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect) as assessed by an investigator.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 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 V Guerrero, MSc., FIACLE principal investigator
Dr. Ruben Velazquez Private Practice
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 and Lens B 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 28 Nov 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 28 Nov 2023). 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 (time frame: 15 minutes). 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 28 Nov 2023.