Visual PerformanceNCT02394756
Investigation of Ocular Signs & Symptoms in Wearers Fitted With Contact Lenses Following Digital Device Use
A study testing Marketed Soft Contact lens, AIR OPTIX® AQUA and Biofinity® in people with Visual Performance, run by Johnson & Johnson Vision Care, Inc. at 1 site in Canada.
Trial summary
The objective of this study is to assess how various silicone hydrogel lenses perform when worn by subjects who are heavy digital device users. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Performance
- What is being tested?
- Marketed Soft Contact lens, AIR OPTIX® AQUA and Biofinity®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Sep 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 40 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 between 18 and 40 years of age.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50D to -8.00D in each eye.
- The subject's refractive cylinder must be no more than -1.25 D cylindrical correction in each eye after vertexing to the corneal plane.
- The subject must have best corrected visual acuity of 0.20 or better in each eye.
- The subject must be a current wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/ week and at least 8 hours/day during the month prior to enrollment.
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- The subject must be using digital devices (any combination of computers, tablets, smartphones, etc.) for at least 8 hours over the course of a typical day.
- The subject should own a wearable pair of spectacles and wear them the day of the baseline visit.
- The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear.
- The subject must meet normal eligibility conditions of binocular vision tests.
- The subject may not have any double vision at near with their habitual contact lens correction.
Who cannot join
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion).
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion).
- Use of any medication that causes side effects similar to side effects experienced when using digital devices, such as subjects reporting headaches associated with birth control pills (at the investigator's discretion).
- Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease.
- Any active ocular infection.
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- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
- Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
- Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- Any known hypersensitivity or allergic reaction to the study products.
- Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- History of binocular abnormality or strabismus.
- Employee of investigational clinic (e.g. Investigator, Coordinator, Technician).
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to assess how various silicone hydrogel lenses perform when worn by subjects who are heavy digital device users.
- Conditions
- Visual Performance
- Being tested
- Marketed Soft Contact lens, AIR OPTIX® AQUA, Biofinity®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed Soft Contact lensDevice
Also called senofilcon A
Replacement schedule every 2 weeks
AIR OPTIX® AQUADevice
Also called lotrafilcon B
Replacement schedule every 4 weeks
Biofinity®Device
Also called comfilcon A
Replacement schedule every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Marketed Soft Contact Lens (Test) | Experimental | Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type. Receives: Device: Marketed Soft Contact lens; Device: AIR OPTIX® AQUA; Device: Biofinity® |
| AIR OPTIX® AQUA | Active comparator | Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type. Receives: Device: Marketed Soft Contact lens; Device: AIR OPTIX® AQUA; Device: Biofinity® |
| Biofinity® | Active comparator | Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type. Receives: Device: Marketed Soft Contact lens; Device: AIR OPTIX® AQUA; Device: Biofinity® |
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. Scores range 0-120.
Measured: 1-Day Follow-up
Subjective Overall Quality of Vision
Subjective Overall quality of vision 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. Scores range 0-120.
Measured: 1-Day 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 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionSep 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 PerformanceStudies 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
- None (open label)
- Enrolment
- 52 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
- NCT02394756
- Sponsor's protocol ID
- CR-5615
- Status last verified
- Mar 2017
- First submitted
- 16 Mar 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
- Investigation of Ocular Signs & Symptoms in Wearers Fitted With Contact Lenses Following Digital Device Use
- ClinicalTrials.gov ID
- NCT02394756
- Acronym / sponsor ID
- CR-5615
- Conditions
- Visual Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess how various silicone hydrogel lenses perform when worn by subjects who are heavy digital device users.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Marketed Soft Contact Lens (Test) | Experimental | Device: Marketed Soft Contact lens, Device: AIR OPTIX® AQUA, Device: Biofinity®Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type. |
| AIR OPTIX® AQUA | Active comparator | Device: Marketed Soft Contact lens, Device: AIR OPTIX® AQUA, Device: Biofinity®Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type. |
| Biofinity® | Active comparator | Device: Marketed Soft Contact lens, Device: AIR OPTIX® AQUA, Device: Biofinity®Subjects will be randomized to wear each of three contact lens types (Marketed Soft Contact lens, AIR OPTIX® AQUA, or Biofinity®) for a 4-week period with each lens type. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 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 between 18 and 40 years of age.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50D to -8.00D in each eye.
- The subject's refractive cylinder must be no more than -1.25 D cylindrical correction in each eye after vertexing to the corneal plane.
- The subject must have best corrected visual acuity of 0.20 or better in each eye.
Key exclusion criteria (14 listed)
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion).
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion).
- Use of any medication that causes side effects similar to side effects experienced when using digital devices, such as subjects reporting headaches associated with birth control pills (at the investigator's discretion).
- Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease.
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 |
|---|---|---|
| Marketed Soft Contact lensAlso: senofilcon AReplacement schedule every 2 weeks | Device | AIR OPTIX® AQUA, Biofinity®, Marketed Soft Contact Lens (Test) |
| AIR OPTIX® AQUAAlso: lotrafilcon BReplacement schedule every 4 weeks | Device | AIR OPTIX® AQUA, Biofinity®, Marketed Soft Contact Lens (Test) |
| Biofinity®Also: comfilcon AReplacement schedule every 4 weeks | Device | AIR OPTIX® AQUA, Biofinity®, Marketed Soft Contact Lens (Test) |
Primary outcome
Subjective Overall Comfort
Time frame: 1-Day 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. Scores range 0-120.
Subjective Overall Quality of Vision
Time frame: 1-Day Follow-up
Subjective Overall quality of vision 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. Scores range 0-120.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marketed Soft Contact lens, AIR OPTIX® AQUA and Biofinity® in people with Visual Performance, run by Johnson & Johnson Vision Care, Inc. 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 11 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 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 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?
Yes. Results are posted in the registry (first posted 25 Apr 2017). 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-Day 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.