Astigmatism BilateralNCT03779503
Comparison of Two Daily Disposable Soft Contact Lenses
A study testing midafilcon A and somofilcon A in people with Astigmatism Bilateral, run by CooperVision, Inc. at 1 site in United States.
Trial summary
The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Astigmatism Bilateral
- What is being tested?
- midafilcon A and somofilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2019to 18 Sep 2019
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- They are between 18 and 40 years of age (inclusive).
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
- They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
- They own a wearable pair of spectacles and wear them on the day of the initial visit.
Show all 9Show fewer
- At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
- They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
- They agree not to participate in other clinical research for the duration of the study.
Who cannot join
- They have an ocular disorder, which would normally contra-indicate contact lens wear.
- They have a systemic disorder, which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
Show all 10Show fewer
- They are pregnant or breastfeeding.
- They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear
- They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.
Read the detailed description
This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.
- Conditions
- Astigmatism Bilateral
- Being tested
- midafilcon A, somofilcon A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midafilcon ADevice
midafilcon A 1 day daily disposable contact lens
somofilcon ADevice
somofilcon A 1 day daily disposable contact lens
| Study group | Role | What they receive |
|---|---|---|
| midafilcon A | Active comparator | Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study. Receives: Device: midafilcon A |
| somofilcon A | Active comparator | Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study. Receives: Device: somofilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Fit - Horizontal Centration
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Measured: Baseline
Lens Fit - Horizontal Centration
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Measured: One Week
Lens Fit - Vertical Centration
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Measured: Baseline
Lens Fit - Vertical Centration
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Measured: One Week
Lens Fit - Corneal Coverage
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Measured: Baseline
Lens Fit - Corneal Coverage
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Measured: One Week
Lens Fit - Lens Movement
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Measured: Baseline
Lens Fit - Lens Movement
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Measured: One Week
Secondary outcomes (2)
Subjective Score for Vision
Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
Measured: Baseline
Subjective Score for Vision
Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start8 Feb 2019
- Primary completion30 Jul 2019
- Study completion18 Sep 2019
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 Astigmatism BilateralStudies 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Morgan, PhD MCOptom FAAO FBCLA, Principal investigator, Eurolens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779503
- Sponsor's protocol ID
- EX-MKTG-99 (C18-649)
- Status last verified
- Sep 2020
- First submitted
- 13 Dec 2018
- Last updated
- 8 Oct 2020
- 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT03779503
- Acronym / sponsor ID
- EX-MKTG-99 (C18-649)
- Conditions
- Astigmatism Bilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 8 Oct 2020
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 was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.
Detailed description
This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midafilcon A | Active comparator | Device: midafilcon ASubjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study. |
| somofilcon A | Active comparator | Device: somofilcon ASubjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- They are between 18 and 40 years of age (inclusive).
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
- They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
Key exclusion criteria (10 listed)
- They have an ocular disorder, which would normally contra-indicate contact lens wear.
- They have a systemic disorder, which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.
- They are aphakic.
- They have had corneal refractive surgery.
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 |
|---|---|---|
| midafilcon Amidafilcon A 1 day daily disposable contact lens | Device | midafilcon A |
| somofilcon Asomofilcon A 1 day daily disposable contact lens | Device | somofilcon A |
Primary outcome
Lens Fit - Horizontal Centration
Time frame: Baseline
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Lens Fit - Horizontal Centration
Time frame: One Week
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Lens Fit - Vertical Centration
Time frame: Baseline
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Lens Fit - Vertical Centration
Time frame: One Week
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Lens Fit - Corneal Coverage
Time frame: Baseline
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Lens Fit - Corneal Coverage
Time frame: One Week
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Lens Fit - Lens Movement
Time frame: Baseline
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Lens Fit - Lens Movement
Time frame: One Week
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
2 secondary outcomes
Subjective Score for Vision
Time frame: Baseline
Subjective Score for Vision
Time frame: One week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Astigmatism Bilateral
Active, not recruiting
Spectacle Prescribing in Early Childhood
Astigmatism Bilateral, Eyeglasses
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.
Philip Morgan, PhD MCOptom FAAO FBCLA principal investigator
Eurolens Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing midafilcon A and somofilcon A in people with Astigmatism Bilateral, run by CooperVision, Inc. at 1 site in United States.
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 9 inclusion and 10 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 8 Oct 2020. 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 United States. 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 8 Oct 2020). 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 - Horizontal Centration (time frame: Baseline). The study lists 8 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 8 Oct 2020.