Visual AcuityNCT03679741
Initial Evaluation of Investigational Lenses Manufactured on a New Production Line
A study testing TEST Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 6 sites in United States.
Trial summary
This study is a randomized, 4-visit, subject-masked, 2x3 bilateral crossover, dispensing trial. Each study lens will be worn bilaterally in a daily wear (DW) modality for at least 6 hours per day and 5 days per week for approximately two weeks each. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- TEST Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Aug 2018to 31 Oct 2018
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject must read and sign the Informed Consent form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Healthy adult males or females age ≥18 and ≤49 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
- The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and -6.00 D.
- The subject's refractive cylinder must be ≤ 1.00 D in each eye.
- The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
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- Subjects must own a wearable pair of spectacles.
- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.
- Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Who cannot join
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any 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, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
- Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
- Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), LASIK, etc.).
- Any Grade 3 or greater slit lamp findings (e.g.., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
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- Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution.
- Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Toric, extended wear, monovision or multi-focal contact lens correction.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.
- History of binocular vision abnormality or strabismus.
- Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
VRC-East
Jacksonville, Florida, 32256
Pickens Eye Care
Pickens, South Carolina, 29671
Botetourt Eyecare, LLC
Roanoke, Virginia, 24153
William J. Bogus, OD, FAAO
Salt Lake City, Utah, 29671
Randall Go, OD
San Francisco, California, 94110
Sacco Eye Group
Vestal, New York, 13850
About this study
This study is a randomized, 4-visit, subject-masked, 2x3 bilateral crossover, dispensing trial. Each study lens will be worn bilaterally in a daily wear (DW) modality for at least 6 hours per day and 5 days per week for approximately two weeks each. The subject will wear either the Test or Control lens twice and the other study lens once.
- Conditions
- Visual Acuity
- Being tested
- CONTROL Lens, TEST Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONTROL LensDevice
Acuvue OASYS
TEST LensDevice
senofilcon A
| Study group | Role | What they receive |
|---|---|---|
| TEST/CONTROL/CONTROL | Experimental | Subjects that are 18 to 49 years of age and current spherical soft contact lens wears will be randomized into one of two lens wear sequences. Subjects will wear the Test and Control lenses for two weeks each with one of the study lenses being worn twice for a total of 6 weeks. Receives: Device: CONTROL Lens; Device: TEST Lens |
| CONTROL/TEST/TEST | Experimental | Subjects that are 18 to 49 years of age and current spherical soft contact lens wears will be randomized into one of two lens wear sequences. Subjects will wear the Test and Control lenses for two weeks each with one of the study lenses being worn twice for a total of 6 weeks. Receives: Device: CONTROL Lens; Device: TEST Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Comfort Score
Overall comfort 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, ages 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: 2-Week Follow-up
Vision Satisfaction in Bright Lighting
Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ 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, ages 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. The Proportion of responses in each category were reported for each lens type.
Measured: 2-Week Follow-up
Distance Monocular LogMAR Visual Acuity
Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart under high illumination low contrast (room illumination > 400 lux and chart luminance 120-200 cd/m2) and low illumination high contrast (room illumination <2.5 lux and chart luminance 2.0 - 5.0 cd/m2 at the 2-week follow-up for each subject eye. The average visual acuity for each lens was reported.
Measured: 2-Week Follow-up
Contact Lens Fitting Acceptance Rate
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at all study visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The percentage of eyes with acceptable lens fit was reported for each lens.
Measured: Up to 2-Week Follow-up
Number of Grade 3 or Higher Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher by lens was reported.
Measured: Up to 2-Week Follow-up
Secondary outcomes (3)
Overall Quality of Vision Score
Overall quality of vision 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, ages 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: 2-Week Follow-up
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, ages 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: 2-Week Follow-up
Overall Quality of Vision Indoors
Overall Quality of Vision Indoors was assessed using the individual item" Overall Quality of Vision Indoors" from questionnaire assessing contact lens performance. This item used the response scale, 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. The Proportion of responses in each category were reported for each lens type.
Measured: 2-Week Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start29 Aug 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
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
- 126 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
- NCT03679741
- Sponsor's protocol ID
- CR-6283
- Status last verified
- Dec 2019
- First submitted
- 19 Sep 2018
- Last updated
- 26 Dec 2019
- 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 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Evaluation of Investigational Lenses Manufactured on a New Production Line
- ClinicalTrials.gov ID
- NCT03679741
- Acronym / sponsor ID
- CR-6283
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Posted 26 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, 4-visit, subject-masked, 2x3 bilateral crossover, dispensing trial. Each study lens will be worn bilaterally in a daily wear (DW) modality for at least 6 hours per day and 5 days per week for approximately two weeks each. The subject will wear either the Test or Control lens twice and the other study lens once.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST/CONTROL/CONTROL | Experimental | Device: CONTROL Lens, Device: TEST LensSubjects that are 18 to 49 years of age and current spherical soft contact lens wears will be randomized into one of two lens wear sequences. Subjects will wear the Test and Control lenses for two weeks each with one of the study lenses being worn twice for a total of 6 weeks. |
| CONTROL/TEST/TEST | Experimental | Device: CONTROL Lens, Device: TEST LensSubjects that are 18 to 49 years of age and current spherical soft contact lens wears will be randomized into one of two lens wear sequences. Subjects will wear the Test and Control lenses for two weeks each with one of the study lenses being worn twice for a total of 6 weeks. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The subject must read and sign the Informed Consent form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Healthy adult males or females age ≥18 and ≤49 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
- The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and -6.00 D.
- The subject's refractive cylinder must be ≤ 1.00 D in each eye.
Key exclusion criteria (14 listed)
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any 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, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
- Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
- Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), LASIK, etc.).
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 |
|---|---|---|
| CONTROL LensAcuvue OASYS | Device | CONTROL/TEST/TEST, TEST/CONTROL/CONTROL |
| TEST Lenssenofilcon A | Device | CONTROL/TEST/TEST, TEST/CONTROL/CONTROL |
Primary outcome
Overall Comfort Score
Time frame: 2-Week Follow-up
Overall comfort 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, ages 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.
Vision Satisfaction in Bright Lighting
Time frame: 2-Week Follow-up
Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ 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, ages 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. The Proportion of responses in each category were reported for each lens type.
Distance Monocular LogMAR Visual Acuity
Time frame: 2-Week Follow-up
Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart under high illumination low contrast (room illumination > 400 lux and chart luminance 120-200 cd/m2) and low illumination high contrast (room illumination <2.5 lux and chart luminance 2.0 - 5.0 cd/m2 at the 2-week follow-up for each subject eye. The average visual acuity for each lens was reported.
Contact Lens Fitting Acceptance Rate
Time frame: Up to 2-Week Follow-up
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at all study visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The percentage of eyes with acceptable lens fit was reported for each lens.
Number of Grade 3 or Higher Slit Lamp Findings
Time frame: Up to 2-Week Follow-up
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher by lens was reported.
3 secondary outcomes
Overall Quality of Vision Score
Time frame: 2-Week Follow-up
Overall Handling Scores
Time frame: 2-Week Follow-up
Overall Quality of Vision Indoors
Time frame: 2-Week Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEST Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 6 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 10 inclusion and 14 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 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 26 Dec 2019). 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?
Overall Comfort Score (time frame: 2-Week Follow-up). The study lists 5 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 26 Dec 2019.