Contact Lens Base Curve (BC) Fit and ComfortPhase 4NCT02537522
Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses
A Phase 4 study testing Contact Lenses with 8.5 BC and Contact Lenses with 9.0 BC in people with Contact Lens Base Curve (BC) Fit and Comfort, run by Johnson & Johnson Vision Care, Inc. at 2 sites in United States.
Trial summary
The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Base Curve (BC) Fit and Comfort
- What is being tested?
- Contact Lenses with 8.5 BC and Contact Lenses with 9.0 BC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2015to 1 Jul 2015
- Phase
- Phase 4
- 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 45 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 no less than 18 and no more than 45 years of age with no presbyopic add.
- The subject must be willing and able to adhere to the instructions set out in the protocol.
- The subject must be an adapted soft contact lens wearer in both eyes.
- The subject must be willing to wear the study contact lenses up to 14 hours/day.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 Diopters (D) to -6.00 D in each eye.
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- The subject must have refractive cylinder less than or equal to 1.00 D in each eye.
- The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
- The subject must require a visual correction in both eyes (no monofit or monovision allowed).
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Who cannot join
- Current 1-DAY ACUVUE® TruEye® wearers
- Anisometropia of 1.00 D or greater
- Any Ocular or systemic allergies or diseases which might interfere with contact lens wear.
- Any Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
- 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.
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- Any ocular infection
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
- Pregnancy or lactation
- Diabetes
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Jacksonville, Florida, 32205
Study site
Jacksonville, Florida, 32256
About this study
The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.
- Being tested
- Contact Lenses with 8.5 BC, Contact Lenses with 9.0 BC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contact Lenses with 8.5 BCDevice
Also called Marketed Daily Disposable Soft Contact Lenses
Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.
Contact Lenses with 9.0 BCDevice
Also called Marketed Daily Disposable Soft Contact Lenses
Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.
| Study group | Role | What they receive |
|---|---|---|
| Test/Control - Phase 1 | Experimental | Over visits 1 and 2, subject will wear Contact Lenses with 8.5 BC in right eye and Contact Lenses with 9.0 BC in left eye in a contralateral manner. Receives: Device: Contact Lenses with 8.5 BC; Device: Contact Lenses with 9.0 BC |
| Control/Test - Phase 1 | Experimental | Over visits 1 and 2, subject will wear Contact Lenses with 9.0 BC in right eye and Contact Lenses with 8.5 BC in left eye in a contralateral manner. Receives: Device: Contact Lenses with 8.5 BC; Device: Contact Lenses with 9.0 BC |
| Test/Control - Phase 2 | Experimental | During Phase 2, subjects will wear a pair of Contact Lenses with 9.0 BC at Period 1 and Contact Lenses with 8.5 BC at Period 2 in a bilateral manner. Receives: Device: Contact Lenses with 8.5 BC; Device: Contact Lenses with 9.0 BC |
| Control/Test - Phase 2 | Experimental | During Phase 2, subjects will wear a pair of Contact Lenses with 8.5 BC at Period 1 and Contact Lenses with 9.0 BC at Period 2 in a bilateral manner. Receives: Device: Contact Lenses with 8.5 BC; Device: Contact Lenses with 9.0 BC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Subjective CLUE Comfort and Keratometry
CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable 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) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter [DK]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.
Measured: 3-day follow-up
Correlation Between Subjective CLUE Comfort and Corneal Diameter
Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable 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) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter [HVID]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.
Measured: 3-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 posted1 Sep 2015 (estimated)
- Study start1 Jul 2015
- Primary completion1 Jul 2015
- Study completion1 Jul 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 Contact Lens Base Curve (BC) Fit and ComfortStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 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
- NCT02537522
- Sponsor's protocol ID
- CR-5730
- Status last verified
- Jun 2017
- First submitted
- 28 Aug 2015
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses
- ClinicalTrials.gov ID
- NCT02537522
- Acronym / sponsor ID
- CR-5730
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Posted 10 Jan 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 determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test/Control - Phase 1 | Experimental | Device: Contact Lenses with 8.5 BC, Device: Contact Lenses with 9.0 BCOver visits 1 and 2, subject will wear Contact Lenses with 8.5 BC in right eye and Contact Lenses with 9.0 BC in left eye in a contralateral manner. |
| Control/Test - Phase 1 | Experimental | Device: Contact Lenses with 8.5 BC, Device: Contact Lenses with 9.0 BCOver visits 1 and 2, subject will wear Contact Lenses with 9.0 BC in right eye and Contact Lenses with 8.5 BC in left eye in a contralateral manner. |
| Test/Control - Phase 2 | Experimental | Device: Contact Lenses with 8.5 BC, Device: Contact Lenses with 9.0 BCDuring Phase 2, subjects will wear a pair of Contact Lenses with 9.0 BC at Period 1 and Contact Lenses with 8.5 BC at Period 2 in a bilateral manner. |
| Control/Test - Phase 2 | Experimental | Device: Contact Lenses with 8.5 BC, Device: Contact Lenses with 9.0 BCDuring Phase 2, subjects will wear a pair of Contact Lenses with 8.5 BC at Period 1 and Contact Lenses with 9.0 BC at Period 2 in a bilateral manner. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 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 no less than 18 and no more than 45 years of age with no presbyopic add.
- The subject must be willing and able to adhere to the instructions set out in the protocol.
- The subject must be an adapted soft contact lens wearer in both eyes.
- The subject must be willing to wear the study contact lenses up to 14 hours/day.
Key exclusion criteria (12 listed)
- Current 1-DAY ACUVUE® TruEye® wearers
- Anisometropia of 1.00 D or greater
- Any Ocular or systemic allergies or diseases which might interfere with contact lens wear.
- Any Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
- 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.
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 |
|---|---|---|
| Contact Lenses with 8.5 BCAlso: Marketed Daily Disposable Soft Contact LensesSubjects will wear the marketed, daily disposable contact lenses in 8.5 BC. | Device | Control/Test - Phase 1, Control/Test - Phase 2, Test/Control - Phase 1, Test/Control - Phase 2 |
| Contact Lenses with 9.0 BCAlso: Marketed Daily Disposable Soft Contact LensesSubjects will wear the marketed, daily disposable contact lenses in 9.0 BC. | Device | Control/Test - Phase 1, Control/Test - Phase 2, Test/Control - Phase 1, Test/Control - Phase 2 |
Primary outcome
Correlation Between Subjective CLUE Comfort and Keratometry
Time frame: 3-day follow-up
CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable 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) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter [DK]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.
Correlation Between Subjective CLUE Comfort and Corneal Diameter
Time frame: 3-day follow-up
Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable 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) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter [HVID]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Contact Lenses with 8.5 BC and Contact Lenses with 9.0 BC in people with Contact Lens Base Curve (BC) Fit and Comfort, run by Johnson & Johnson Vision Care, Inc. at 2 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 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 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?
Correlation Between Subjective CLUE Comfort and Keratometry (time frame: 3-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 11 Jul 2017.