Visual AcuityNCT02349438
Assessment of Contact Lens Wettability Using Wavefront Aberrometry
A study testing senofilcon A and lotrafilcon B in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in Australia.
Trial summary
This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- senofilcon A and lotrafilcon B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2014to May 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
- Healthy males or females that are at least 18 to no more than 40 years of age.
- 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 possess a wearable pair of spectacles with distance vision correction which provide satisfactory vision.
- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of lens wear per week for a minimum of 1 month prior to the study) or has sufficient prior experience with soft contact lens wear (defined as a minimum of 30 days of lens wear during the last 5 years).
- The subject's vertexed best sphere distance refraction must be between -0.75 and -5.00 D in both eyes.
- Cylinder refraction less than or equal to -0.75 D in both eyes (any axis).
- The subject must have corrected visual acuity of 20/20 or better in each eye.
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.
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- Any known hypersensitivity or allergic reaction to contact lens solutions or sodium fluorescein dye.
- Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
- Current wearers of rigid or hybrid contact lenses.
Show all 13Show fewer
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- History of binocular vision abnormality or strabismus.
- Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician).
- Clinically significant (grade 3 or 4) corneal edema, pterygium, corneal vascularization, corneal staining, or any other abnormalities of the cornea or conjunctiva which may interfere with the study measurements.
- Strabismus, suppression or amblyopia.
- Any ocular infection.
Trial locations and contacts
1 site in 1 country.
About this study
This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.
- Conditions
- Visual Acuity
- Being tested
- senofilcon A, lotrafilcon B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
senofilcon ADevice
A soft spherical contact lens
lotrafilcon BDevice
| Study group | Role | What they receive |
|---|---|---|
| senofilcon A | Experimental | The lenses will be worn for 2 hours in both eyes, and not dispensed Receives: Device: senofilcon A; Device: lotrafilcon B |
| lotrafilcon A | Active comparator | The lenses will be worn for 2 hours in both eyes, and not dispensed Receives: Device: senofilcon A; Device: lotrafilcon B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking
Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
Measured: 2 hours post insertion
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink
Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
Measured: 2 hours post insertion
Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink
Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
Measured: 2 hours post insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionMay 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 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
- NCT02349438
- Sponsor's protocol ID
- CR-5685
- Status last verified
- Nov 2016
- First submitted
- 22 Jan 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
- Assessment of Contact Lens Wettability Using Wavefront Aberrometry
- ClinicalTrials.gov ID
- NCT02349438
- Acronym / sponsor ID
- CR-5685
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Posted 20 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| senofilcon A | Experimental | Device: senofilcon A, Device: lotrafilcon BThe lenses will be worn for 2 hours in both eyes, and not dispensed |
| lotrafilcon A | Active comparator | Device: senofilcon A, Device: lotrafilcon BThe lenses will be worn for 2 hours in both eyes, and not dispensed |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy males or females that are at least 18 to no more than 40 years of age.
- 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 possess a wearable pair of spectacles with distance vision correction which provide satisfactory vision.
- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of lens wear per week for a minimum of 1 month prior to the study) or has sufficient prior experience with soft contact lens wear (defined as a minimum of 30 days of lens wear during the last 5 years).
Key exclusion criteria (13 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.
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- Any known hypersensitivity or allergic reaction to contact lens solutions or sodium fluorescein dye.
- Any previous 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 AA soft spherical contact lens | Device | lotrafilcon A, senofilcon A |
| lotrafilcon B | Device | lotrafilcon A, senofilcon A |
Primary outcome
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking
Time frame: 2 hours post insertion
Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink
Time frame: 2 hours post insertion
Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink
Time frame: 2 hours post insertion
Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
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 senofilcon A and lotrafilcon B in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in Australia.
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 8 inclusion and 13 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 Australia. 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 20 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?
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking (time frame: 2 hours post insertion). The study lists 3 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.