Visual AcuityBASSNCT03454542
Assessment of Comfort & Ocular Surface Parameters w Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses
A study testing Menicon Modified Lens Design in people with Visual Acuity and Contact Lens Comfort, run by Menicon Co., Ltd. at 1 site in Canada.
Trial summary
A comparison of two lens designs manufactured in the same material. The hypothesis is the subjectively rated performance of comfort, vision and lens handling will be better with the modified design compared to the initial design Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity, Contact Lens Comfort
- What is being tested?
- Menicon Modified Lens Design
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 14 Feb 2018to 29 Mar 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- 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;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is of Caucasian heritage;
- Habitually wears soft spherical daily disposable contact lenses with a power between
- -0.50 to -2.75D (inclusive);
Show all 10Show fewer
- Demonstrates an acceptable fit with both study CL designs (initial \& modified);
- Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with both study CL designs;
- Has a manifest cylindrical spectacle refraction that does not exceed -1.00DC in either eye;
- Should own a wearable pair of spectacles. -
Who cannot join
- Is participating in any concurrent clinical or research study;
- 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 the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);
- Is aphakic;
- Has undergone refractive error surgery; -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Comfort and Ocular Surface Parameters With Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses (BASS)
A comparison of two lens designs manufactured in the same material. The hypothesis is the subjectively rated performance of comfort, vision and lens handling will be better with the modified design compared to the initial design
Read the detailed description
The objectives of the study are
- to identify possible reasons for the different comfort and vision experience in Japanese CL wearers compared to Caucasian CL wearers and
- to assess whether the modification of lens thickness in the optical zone results in increased comfort and reduced visual acuity fluctuations in Caucasian eyes.
- Conditions
- Visual Acuity, Contact Lens Comfort
- Being tested
- Menicon Modified Lens Design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menicon Modified Lens DesignDevice
Randomized in a daily wear, single day (6 hours or more) evaluation
| Study group | Role | What they receive |
|---|---|---|
| Menicon DSRB Redesign | Experimental | Menicon DSRB Modified Lens Design is a single use contact lens with revised thickness specifications worn for 6 hours or more. Receives: Device: Menicon Modified Lens Design |
| Menicon DSRB Original Design | Active comparator | Menicon DSRB Initial Lens Design is a single use contact lens with the original thickness specifications worn for 6 hours or more. Receives: Device: Menicon Modified Lens Design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's subjective rating of comfort, Questionnaire
Participants rate their eye comfort by subjective questionnaire (non-annotated scale, 0-100, 0=painful, 100=can't feel the lenses)
Measured: 2 Days
Participant's subjective rating of vision, Questionnaire
Participants rate their vision by subjective questionnaire (non-annotated scale, 0-100, 0=not at all sharp/clear, 100=sharp/clear
Measured: 2 Days
Participant's subjective rating of lens handling, Questionnaire
Participants rate their ability to handle the contact lens by subjective questionnaire (non-annotated scale, 0-100, 0=very difficult, 100=very easy
Measured: 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start14 Feb 2018
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies 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
- This will be a double-masked, cross-over, bilateral wear study design with five (5) study visits across three (3) study visit days. Participants will be dispensed and wear both the initial and modified lens design for a total of six (6) hours each on two (2) separate visit days, with the order of lens wear being randomized; participants will be allowed to leave the CCLR on their lens wearing days between dispense and follow-up visit.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menicon Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454542
- Sponsor's protocol ID
- P/626/17/M
- Acronym
- BASS
- Status last verified
- Mar 2018
- First submitted
- 20 Feb 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Comfort and Ocular Surface Parameters With Novel Designs of Daily Disposable Silicone Hydrogel Contact Lenses (BASS)
- ClinicalTrials.gov ID
- NCT03454542
- Acronym / sponsor ID
- BASS / P/626/17/M
- Conditions
- Visual Acuity, Contact Lens Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Menicon Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 6 Mar 2018 (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.
A comparison of two lens designs manufactured in the same material. The hypothesis is the subjectively rated performance of comfort, vision and lens handling will be better with the modified design compared to the initial design
Detailed description
The objectives of the study are
- to identify possible reasons for the different comfort and vision experience in Japanese CL wearers compared to Caucasian CL wearers and
- to assess whether the modification of lens thickness in the optical zone results in increased comfort and reduced visual acuity fluctuations in Caucasian eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This will be a double-masked, cross-over, bilateral wear study design with five (5) study visits across three (3) study visit days. Participants will be dispensed and wear both the initial and modified lens design for a total of six (6) hours each on two (2) separate visit days, with the order of lens wear being randomized; participants will be allowed to leave the CCLR on their lens wearing days between dispense and follow-up visit.
| Arm | Type | Receives |
|---|---|---|
| Menicon DSRB Redesign | Experimental | Device: Menicon Modified Lens DesignMenicon DSRB Modified Lens Design is a single use contact lens with revised thickness specifications worn for 6 hours or more. |
| Menicon DSRB Original Design | Active comparator | Device: Menicon Modified Lens DesignMenicon DSRB Initial Lens Design is a single use contact lens with the original thickness specifications worn for 6 hours or more. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Is at least 18 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is of Caucasian heritage;
- Habitually wears soft spherical daily disposable contact lenses with a power between
Key exclusion criteria (8 listed)
- Is participating in any concurrent clinical or research study;
- 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 the diagnostic pharmaceuticals to be 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 |
|---|---|---|
| Menicon Modified Lens DesignRandomized in a daily wear, single day (6 hours or more) evaluation | Device | Menicon DSRB Original Design, Menicon DSRB Redesign |
Primary outcome
Participant's subjective rating of comfort, Questionnaire
Time frame: 2 Days
Participants rate their eye comfort by subjective questionnaire (non-annotated scale, 0-100, 0=painful, 100=can't feel the lenses)
Participant's subjective rating of vision, Questionnaire
Time frame: 2 Days
Participants rate their vision by subjective questionnaire (non-annotated scale, 0-100, 0=not at all sharp/clear, 100=sharp/clear
Participant's subjective rating of lens handling, Questionnaire
Time frame: 2 Days
Participants rate their ability to handle the contact lens by subjective questionnaire (non-annotated scale, 0-100, 0=very difficult, 100=very easy
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 5 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menicon Modified Lens Design in people with Visual Acuity and Contact Lens Comfort, run by Menicon Co., Ltd. at 1 site in Canada.
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 10 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 5 Oct 2018. 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 Canada. 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?
Participant's subjective rating of comfort, Questionnaire (time frame: 2 Days). The study lists 3 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 5 Oct 2018.