AstigmatismNCT05805085
Clinical Evaluation of Hydrogel and Silicone Hydrogel Daily Disposable Toric Contact Lenses
A study testing Lens A and Lens B in people with Astigmatism, run by CooperVision, Inc. at 1 site in Spain.
Trial summary
This study was to evaluate the patient subjective experiences of two daily disposable 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 and Lens B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2023to 16 Nov 2023
- 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 was eligible for inclusion in the study if he/she:
- 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 at least 8 hours a day, 5 days a week.
- Is willing and able to follow instructions and maintain the appointment schedule.
Show all 13Show fewer
- Habitual soft contact lens wearers who currently wear toric contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
- Has a contact lens spherical prescription between plano to - 10.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.
- Has refractive astigmatism no less than -0.75D and no more than 1.75D 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.
Who cannot join
- A person was excluded from the study if he/she:
- 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
Official title: Clinical Evaluation of Biomedics 1 Day Toric and MyDay Toric
This study was to evaluate the patient subjective experiences of two daily disposable toric contact lenses.
Read the detailed description
This was a participant masked, interventional, prospective, direct refit, bilateral wear study. The purpose of this study was to evaluate the patient subjective experiences of a hydrogel daily disposable toric contact lens when compared to a silicone hydrogel daily disposable toric contact lens after 15 minutes of daily wear each.
- Conditions
- Astigmatism
- Being tested
- Lens A, Lens B
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens ADevice
Hydrogel Daily Disposable Toric Contact Lens for 15 minutes
Lens BDevice
Silicone Hydrogel Daily Disposable Toric Contact Lens for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Lens A | Experimental | Participants wore Lens A for 15 minutes (Period 1) Receives: Device: Lens A |
| Lens B | Experimental | 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.
Subjective Handling at Insertion, Dispensing Visit
Subjective handling an lens insertion was assessed at the dispending visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.
Measured: 15 minutes
Subjecting Handling at Insertion, Follow-up Visit
Subjective handling at lens insertion was assessed at the follow-up visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.
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 posted7 Apr 2023
- Study start10 Jan 2023
- Primary completion16 Nov 2023
- Study completion16 Nov 2023
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
- Juan G Carracedo Rodríguez, OD, MSc, PhD, Principal investigator, University Complutense of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805085
- Sponsor's protocol ID
- EX-MKTG-146
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2023
- Last updated
- 12 Dec 2024
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Biomedics 1 Day Toric and MyDay Toric
- ClinicalTrials.gov ID
- NCT05805085
- Acronym / sponsor ID
- EX-MKTG-146
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was to evaluate the patient subjective experiences of two daily disposable toric contact lenses.
Detailed description
This was a participant masked, interventional, prospective, direct refit, bilateral wear study. The purpose of this study was to evaluate the patient subjective experiences of a hydrogel daily disposable toric contact lens when compared to a silicone hydrogel daily disposable toric contact lens 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 | Experimental | Device: Lens AParticipants wore Lens A for 15 minutes (Period 1) |
| Lens B | Experimental | Device: Lens BParticipants wore 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 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 at least 8 hours a day, 5 days a week.
- Is willing and able to follow instructions and maintain the appointment schedule.
Key exclusion criteria (8 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 AHydrogel Daily Disposable Toric Contact Lens for 15 minutes | Device | Lens A |
| Lens BSilicone Hydrogel Daily Disposable Toric Contact Lens for 15 minutes | Device | Lens B |
Primary outcome
Subjective Handling at Insertion, Dispensing Visit
Time frame: 15 minutes
Subjective handling an lens insertion was assessed at the dispending visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.
Subjecting Handling at Insertion, Follow-up Visit
Time frame: 15 minutes
Subjective handling at lens insertion was assessed at the follow-up visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Astigmatism
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
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.
Juan G Carracedo Rodríguez, OD, MSc, PhD principal investigator
University Complutense of Madrid
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 Astigmatism, run by CooperVision, Inc. at 1 site in Spain.
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 8 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 12 Dec 2024. 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 Spain. 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 12 Dec 2024). 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?
Subjective Handling at Insertion, Dispensing Visit (time frame: 15 minutes). The study lists 2 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 12 Dec 2024.