AstigmatismNCT03134248
Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses
A study testing Dailies Aquacomfort Plus Toric, 1-Day Acuvue Moist for Astigmatism and MyDay Toric in people with Astigmatism, run by CooperVision, Inc. at 1 site in Canada.
Trial summary
Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric lenses Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Astigmatism
- What is being tested?
- Dailies Aquacomfort Plus Toric, 1-Day Acuvue Moist for Astigmatism and MyDay Toric
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 19 Oct 2016to 12 Apr 2017
- Phase
- Interventional
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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has had a self-reported oculo-visual examination in the last two years.
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is an adapted soft contact lens wearer;
- Is willing to wear contact lens in both eyes for the duration of the study;
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- Has a minimum spectacle astigmatism of - 0.75;
- Can be fit with the three study contact lens types in the powers available;
- Has a visual acuity of 20/30 or better in each eye with habitual correction, or 20/20 best corrected vision (for binocular distance acuity);
- 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;
- For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Who cannot join
- Is participating in any concurrent clinical trial;
- Has any known active* ocular disease and/or infection;
- 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 a study outcome variable;
- Has known sensitivity to fluorescein dye or products to be used in the study;
- Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
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- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric lenses
Read the detailed description
Prospective, double-masked (investigator and participant), bilateral, randomized, cross-over dispensing study comparing the MyDay Toric (test) against the 1-day Acuvue Moist for Astigmatism (control), and Dailies Aquacomfort Plus Toric (control) lenses
- Conditions
- Astigmatism
- Being tested
- Dailies Aquacomfort Plus Toric, 1-Day Acuvue Moist for Astigmatism, MyDay Toric
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dailies Aquacomfort Plus ToricDevice
Also called DACP
daily disposable contact lens
1-Day Acuvue Moist for AstigmatismDevice
Also called 1-Day AM
daily disposable contact lens
MyDay ToricDevice
Also called MDT
daily disposable contact lens
| Study group | Role | What they receive |
|---|---|---|
| MyDay Toric | Experimental | Participants were randomized to wear a new pair of MyDay Toric lenses each day for one week during the cross over study Receives: Device: MyDay Toric |
| 1-Day Acuvue Moist for Astigmatism | Active comparator | Participants were randomized to wear a new pair of 1-Day Acuvue Moist Toric lenses each day for one week during the cross over study Receives: Device: 1-Day Acuvue Moist for Astigmatism |
| Dailies Aquacomfort Plus Toric | Active comparator | Participants were randomized to wear a new pair of Dailies Aquacomfort Plus Toric lenses each day for one week during the cross over study Receives: Device: Dailies Aquacomfort Plus Toric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.
Measured: 1 week
Dryness
Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness
Measured: 1 week
Visual Quality
Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied
Measured: 1 week
Lens Preference With Respect to Overall Comfort
Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference
Measured: 1 week
Lens Preference With Respect to Visual Quality
Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start19 Oct 2016
- Primary completion12 Apr 2017
- Study completion12 Apr 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134248
- Sponsor's protocol ID
- EX-MKTG-72
- Status last verified
- Aug 2019
- First submitted
- 12 Apr 2017
- Last updated
- 12 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No