Visual AcuityNCT04093258
Comparison of Two Silicone Hydrogel Multifocal Contact Lenses
A study testing Dailies Total 1® Multifocal Contact Lenses and Air Optix® Multifocal Contact Lenses Plus HydraGlyde® in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 3 sites in United States.
Trial summary
This is a single-masked, randomized-controlled, dispensing clinical trial. A total of approximately 40 eligible hyperopic and myopic subjects will be targeted to complete the study. The subjects will be fit in the first study lens and worn for a total of 8-12 days following a 7±3 day wash-out period. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- Dailies Total 1® Multifocal Contact Lenses and Air Optix® Multifocal Contact Lenses Plus HydraGlyde®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Aug 2019to 11 Dec 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Potential subjects must satisfy all the following criteria to be enrolled in the study:
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be between 40 and 70 years of age (inclusive).
- The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D or -1.25 D to -4.00 D in each eye.
- The subject's refractive cylinder must be ≤0.75 D in each eye.
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- The subject's ADD power must be in the range of +0.75 D to +2.50 D.
- The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
- Subjects must own a wearable pair of spectacles if required for their distance vision.
- The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration).
- The subject must either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or lactating.
- Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
- Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
- Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
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- Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, cataract surgery, retinal surgery, etc.).
- A history of amblyopia, strabismus or binocular vision abnormality.
- Any current ocular infection or inflammation.
- Any current ocular abnormality that may interfere with contact lens wear.
- Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids.
- Use of any ocular medication, with the exception of rewetting drops.
- History of herpetic keratitis.
- Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- Any known hypersensitivity or allergic reaction to OPTI-FREE® Puremoist® multipurpose care solution, sodium fluorescein or single-use preservative free rewetting drop solution.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
ProCare Vision Centers
Granville, Ohio, 43023
Optometry Group, LLC
Memphis, Tennessee, 38111
Visual Eyes
Roswell, Georgia, 30076
About this study
This is a single-masked, randomized-controlled, dispensing clinical trial. A total of approximately 40 eligible hyperopic and myopic subjects will be targeted to complete the study. The subjects will be fit in the first study lens and worn for a total of 8-12 days following a 7±3 day wash-out period. The procedures will be repeated for the 2nd lens.
- Conditions
- Visual Acuity
- Being tested
- Dailies Total 1® Multifocal Contact Lenses, Air Optix® Multifocal Contact Lenses Plus HydraGlyde®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dailies Total 1® Multifocal Contact LensesDevice
TEST
Air Optix® Multifocal Contact Lenses Plus HydraGlyde®Device
CONTROL
| Study group | Role | What they receive |
|---|---|---|
| Test/Control | Experimental | Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting. Receives: Device: Dailies Total 1® Multifocal Contact Lenses; Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde® |
| Control/Test | Experimental | Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting. Receives: Device: Dailies Total 1® Multifocal Contact Lenses; Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Lens Centration
Lens centration was assessed using a biomicroscope and was graded using the scale (Grade: 0, 1,2) with grade 0 represent Centered, Grade 1 = Slightly Decentered and Grade 2= substantially decentered. The data was then dichotomized into two groups: those with grade 1 or higher and those with grade 0 (centered). The percentage of participants with Grade 0 Lens centration was reported.
Measured: 6 to 8 days
Percentage of Participants With Lens Movement
Lens movement in primary gaze was assessed using a biomicroscope and was graded using the scale (Insufficient/Unacceptable (-2), Minimal/Acceptable (-1), Optimal (0), Moderate/Acceptable (+1) and Excessive/Unacceptable (+2)) with Optimal (0) representing no lens movement. The data was then dichotomized into two groups: those with Optimal Lens movement and otherwise (-2, -1, +1 and +2). The percentage of participants with Optimal Lens movement was reported.
Measured: 6 to 8 days
Secondary outcomes (1)
Overall Handling Scores
Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, aged 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Measured: 6 to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start26 Aug 2019
- Primary completion11 Dec 2019
- Study completion11 Dec 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 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093258
- Sponsor's protocol ID
- CR-6344
- Status last verified
- Nov 2021
- First submitted
- 16 Sep 2019
- Last updated
- 1 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Silicone Hydrogel Multifocal Contact Lenses
- ClinicalTrials.gov ID
- NCT04093258
- Acronym / sponsor ID
- CR-6344
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Posted 16 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-masked, randomized-controlled, dispensing clinical trial. A total of approximately 40 eligible hyperopic and myopic subjects will be targeted to complete the study. The subjects will be fit in the first study lens and worn for a total of 8-12 days following a 7±3 day wash-out period. The procedures will be repeated for the 2nd lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test/Control | Experimental | Device: Dailies Total 1® Multifocal Contact Lenses, Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde®Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting. |
| Control/Test | Experimental | Device: Dailies Total 1® Multifocal Contact Lenses, Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde®Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Potential subjects must satisfy all the following criteria to be enrolled in the study:
Key exclusion criteria (16 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating 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 |
|---|---|---|
| Dailies Total 1® Multifocal Contact LensesTEST | Device | Control/Test, Test/Control |
| Air Optix® Multifocal Contact Lenses Plus HydraGlyde®CONTROL | Device | Control/Test, Test/Control |
Primary outcome
Percentage of Participants With Lens Centration
Time frame: 6 to 8 days
Lens centration was assessed using a biomicroscope and was graded using the scale (Grade: 0, 1,2) with grade 0 represent Centered, Grade 1 = Slightly Decentered and Grade 2= substantially decentered. The data was then dichotomized into two groups: those with grade 1 or higher and those with grade 0 (centered). The percentage of participants with Grade 0 Lens centration was reported.
Percentage of Participants With Lens Movement
Time frame: 6 to 8 days
Lens movement in primary gaze was assessed using a biomicroscope and was graded using the scale (Insufficient/Unacceptable (-2), Minimal/Acceptable (-1), Optimal (0), Moderate/Acceptable (+1) and Excessive/Unacceptable (+2)) with Optimal (0) representing no lens movement. The data was then dichotomized into two groups: those with Optimal Lens movement and otherwise (-2, -1, +1 and +2). The percentage of participants with Optimal Lens movement was reported.
1 secondary outcome
Overall Handling Scores
Time frame: 6 to 8 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dailies Total 1® Multifocal Contact Lenses and Air Optix® Multifocal Contact Lenses Plus HydraGlyde® in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. 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 11 inclusion and 16 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 1 Dec 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?
Yes. Results are posted in the registry (first posted 16 Feb 2021). 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?
Percentage of Participants With Lens Centration (time frame: 6 to 8 days). 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 1 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.