Visual AcuityNCT02427477
A Comparison of Two Daily Disposable Soft Contact Lenses
A study testing senofilcon A and delefilcon A in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 6 sites in United States.
Trial summary
Approximately 120 subjects will be comparing two soft contact lenses for one week each. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- senofilcon A and delefilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2015to Apr 2015
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject must read, understand, and sign the Statement of Informed Consent, and receive a fully executed copy of the form.
- The subject must be appear able and willing to adhere to instruction set forth in this clinical protocol.
- The subject be between (and including) 18 and 39 years of age.
- The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 to -6.00 D in each eye.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
Who cannot join
- Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any autoimmune disease or use of any medication, which may interfere with contact lens wear.
- Entropoin, Ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
- Any previous, or planned ocular or intraocular surgery (e.g. radial keratotomy, 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 inflammatory event (e.g. past peripheral ulcer or round scar), or any other ocular abnormality that may contraindicate contact lens wear.
Show all 12Show fewer
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Monovision, multifocal, toric, or extended wear contact lens correction.
- Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV) by self-report.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Jacksonville Beach, Florida, 32250
Study site
Longwood, Florida, 32779
Study site
Montgomery, Alabama, 36109
Study site
Salem, Virginia, 24153
Study site
Westerville, Ohio, 43081
Study site
Winter Park, Florida, 32792
About this study
Approximately 120 subjects will be comparing two soft contact lenses for one week each.
- Conditions
- Visual Acuity
- Being tested
- senofilcon A, delefilcon A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
senofilcon ADevice
Also called senofilcon A Prototype
Subjects will wear the contact lenses in both eyes for seven days
delefilcon ADevice
Also called Dailies Total 1
Subjects will wear the contact lenses in both eyes for seven days
| Study group | Role | What they receive |
|---|---|---|
| senofilcon A/ delefilcon A/ senofilcon A | Experimental | Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third. Receives: Device: senofilcon A; Device: delefilcon A |
| delefilcon A/senofilcon A/ delfilcon A | Active comparator | Subjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the delefilcon A contact lens then wore the senofilcon A contact lens second and then wore the Control lens delefilcon A contact lens third. Receives: Device: senofilcon A; Device: delefilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Overall Comfort
Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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.
Measured: 1-week Follow-up
Subjective Overall Vision
Subjective Overall Vision was evaluated using the Contact Lens User Experience Vison scores (CLUE). 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.
Measured: 1-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 posted28 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionApr 2015
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
- 120 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
- NCT02427477
- Sponsor's protocol ID
- CR-5698
- Status last verified
- Jul 2016
- First submitted
- 22 Apr 2015
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Daily Disposable Soft Contact Lenses
- ClinicalTrials.gov ID
- NCT02427477
- Acronym / sponsor ID
- CR-5698
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Posted 13 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 120 subjects will be comparing two soft contact lenses for one week each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| senofilcon A/ delefilcon A/ senofilcon A | Experimental | Device: senofilcon A, Device: delefilcon ASubjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third. |
| delefilcon A/senofilcon A/ delfilcon A | Active comparator | Device: senofilcon A, Device: delefilcon ASubjects were randomized to one two lens wear sequences. Subjects randomized to this sequence first wore the delefilcon A contact lens then wore the senofilcon A contact lens second and then wore the Control lens delefilcon A contact lens third. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The subject must read, understand, and sign the Statement of Informed Consent, and receive a fully executed copy of the form.
- The subject must be appear able and willing to adhere to instruction set forth in this clinical protocol.
- The subject be between (and including) 18 and 39 years of age.
- The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 to -6.00 D in each eye.
Key exclusion criteria (12 listed)
- Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any autoimmune disease or use of any medication, which may interfere with contact lens wear.
- Entropoin, Ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
- Any previous, or planned ocular or intraocular surgery (e.g. radial keratotomy, 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 |
|---|---|---|
| senofilcon AAlso: senofilcon A PrototypeSubjects will wear the contact lenses in both eyes for seven days | Device | delefilcon A/senofilcon A/ delfilcon A, senofilcon A/ delefilcon A/ senofilcon A |
| delefilcon AAlso: Dailies Total 1Subjects will wear the contact lenses in both eyes for seven days | Device | delefilcon A/senofilcon A/ delfilcon A, senofilcon A/ delefilcon A/ senofilcon A |
Primary outcome
Subjective Overall Comfort
Time frame: 1-week Follow-up
Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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.
Subjective Overall Vision
Time frame: 1-week Follow-up
Subjective Overall Vision was evaluated using the Contact Lens User Experience Vison scores (CLUE). 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- 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 senofilcon A and delefilcon A 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 6 inclusion and 12 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 19 Jun 2018. 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 13 Jun 2016). 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?
Subjective Overall Comfort (time frame: 1-week Follow-up). 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 19 Jun 2018.