Refractive Error - Myopia BilateralDDHydNCT04671108
Comparative Clinical Performance of 59% Hioxifilcon A Contact Lenses vs. Marketed Hydrogel Contact Lenses
A study testing Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA) in people with Refractive Error - Myopia Bilateral, run by Vision Service Plan at 3 sites in United States.
Trial summary
The study will compare the short-term clinical performance and wearer and practitioner acceptability of a new-to-market spherical daily disposable (DD) hydrogel soft contact lens to a currently marketed spherical DD hydrogel soft contact lens. Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Error - Myopia Bilateral
- What is being tested?
- Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Nov 2020to 18 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently wearing spherical DD contact lenses at least 5 days/week
- Vision correctable to 20/30 acuity in each eye with spherical DD contact lenses
- No ocular or systemic disease that contra-indicates soft contact lens wear
Who cannot join
- Participating in another clinical trial
- Vision not correctable to 20/30
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ross Eyecare
Atlanta, Georgia, 30324
Primary Eyecare Group
Brentwood, Tennessee, 37027
Professional VisionCare
Westerville, Ohio, 43081
About this study
Official title: Comparative Clinical Performance of 59% Hioxifilcon A Daily Disposable Contact Lenses vs. Marketed Daily Disposable Hydrogel Contact Lenses
The study will compare the short-term clinical performance and wearer and practitioner acceptability of a new-to-market spherical daily disposable (DD) hydrogel soft contact lens to a currently marketed spherical DD hydrogel soft contact lens.
Read the detailed description
This randomized clinical trial will compare the short-term clinical performance, and wearer acceptability of a new-to-market hioxifilcon A spherical daily DD contact lenses against marketed DD lenses in a short cross-over clinical trial.
The primary outcome variable for this study is overall subjective comfort.
- Conditions
- Refractive Error - Myopia Bilateral
- Being tested
- Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)Device
Daily disposable contact lens wear for 1 week
| Study group | Role | What they receive |
|---|---|---|
| Test to Moist | Experimental | 1 week of Test DD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses. Receives: Device: Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA) |
| Moist to Test | Active comparator | 1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test DD contact lenses. Receives: Device: Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall subjective comfort
Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)
Measured: 1 week after contact lens wear
Overall subjective comfort
Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)
Measured: 2 weeks after contact lens wear
Secondary outcomes (3)
End of day subjective comfort
Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)
Measured: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
Subjective vision
Subjective vision rating on a scale of 0 (Not at all sharp/clear) to 10 (Sharp/Clear)
Measured: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
Overall subjective lens preference
Forced choice subjective preference for either lens type (1-Day ACUVUE® MOIST or Test DD contact lens) or no preference. i.e. three options presented and participant selects one option.
Measured: Visit 3 - After approximately 2 weeks of contact lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start11 Nov 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive Error - Myopia 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
- Model description
- Randomized cross-over with 1 week of lens wear with each contact lens type.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vision Service Plan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671108
- Sponsor's protocol ID
- VS-20-02
- Acronym
- DDHyd
- Status last verified
- Jul 2021
- First submitted
- 7 Dec 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Performance of 59% Hioxifilcon A Daily Disposable Contact Lenses vs. Marketed Daily Disposable Hydrogel Contact Lenses
- ClinicalTrials.gov ID
- NCT04671108
- Acronym / sponsor ID
- DDHyd / VS-20-02
- Conditions
- Refractive Error - Myopia Bilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vision Service PlanIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare the short-term clinical performance and wearer and practitioner acceptability of a new-to-market spherical daily disposable (DD) hydrogel soft contact lens to a currently marketed spherical DD hydrogel soft contact lens.
Detailed description
This randomized clinical trial will compare the short-term clinical performance, and wearer acceptability of a new-to-market hioxifilcon A spherical daily DD contact lenses against marketed DD lenses in a short cross-over clinical trial.
The primary outcome variable for this study is overall subjective comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomized cross-over with 1 week of lens wear with each contact lens type.
| Arm | Type | Receives |
|---|---|---|
| Test to Moist | Experimental | Device: Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)1 week of Test DD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses. |
| Moist to Test | Active comparator | Device: Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test DD contact lenses. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Currently wearing spherical DD contact lenses at least 5 days/week
- Vision correctable to 20/30 acuity in each eye with spherical DD contact lenses
- No ocular or systemic disease that contra-indicates soft contact lens wear
Key exclusion criteria (2 listed)
- Participating in another clinical trial
- Vision not correctable to 20/30
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 |
|---|---|---|
| Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)Daily disposable contact lens wear for 1 week | Device | Moist to Test, Test to Moist |
Primary outcome
Overall subjective comfort
Time frame: 1 week after contact lens wear
Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)
Overall subjective comfort
Time frame: 2 weeks after contact lens wear
Subjective comfort rating on a scale of 0 (Painful) to 10 (Can't feel the lenses)
3 secondary outcomes
End of day subjective comfort
Time frame: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
Subjective vision
Time frame: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
Overall subjective lens preference
Time frame: Visit 3 - After approximately 2 weeks of contact lens wear
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Refractive Error - Myopia Bilateral
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA) in people with Refractive Error - Myopia Bilateral, run by Vision Service Plan at 3 sites 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 3 inclusion and 2 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 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall subjective comfort (time frame: 1 week after contact lens wear). 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 23 Jul 2021.