Refractive ErrorNCT01875471
Clinical Evaluation of Two Daily Disposable Contact Lenses
A study testing delefilcon A and narafilcon A in people with Refractive Error, run by Johnson & Johnson Vision Care, Inc. at 11 sites in United Kingdom.
Trial summary
The objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Error
- What is being tested?
- delefilcon A and narafilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- Jun 2013to Aug 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject must be between 18 and 45 years of age (inclusive)with no presbyopic add.
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).
- The subject must be willing to wear the study lenses for at least 8 hours per day, at least 6 days between visits.
- The subject must be a current successful spherical soft contact lens wearer in both eyes.
- The subject must appear willing and able to adhere to the instructions set forth in this clinical protocol.
- The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D (inclusive) in each eye.
Show all 9Show fewer
- The subject's refractive astigmatism must be less than or equal to -0.75D in both eyes.
- The subject must have corrective visual acuity of 6/9 (20/30) or better in each eye.
- The subject must require a visual correction in both eyes (no monofit or monovision allowed).
Who cannot join
- 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.
- Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or infiltrates 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 ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Show all 14Show fewer
- Currently pregnant or lactating (subject who become pregnant during the study will be discontinued).
- Diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).
- Amblyopia
- Evidence of lid abnormality or infection (including blepharitis/meibomitis)
- Conjunctival abnormality or infection.
- Any active ocular disease.
- Employee or family member of the staff of the investigational site.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites
Study site
Brighton, BN1 1RH
Study site
Cardiff, South Glamorgan, CF24 3RQ
Study site
Eastcote, Pinner, Middlesex, HA5 1RJ
Study site
Farnham, Surrey, GU9 7EN
Study site
Hay-on-wye, Herefordshire, HR3 5EQ
Study site
Knowle, Bristol, BS4 2AL
Study site
London, N2 8AG
Study site
London, NW4 3FB
Study site
Norwich, NR2 1PB
Study site
Portchester, Hampshire, PO16 9UN
Study site
St Albans, Herts, AL1 3LH
About this study
The objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye.
- Conditions
- Refractive Error
- Being tested
- delefilcon A, narafilcon A
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delefilcon ADevice
Also called DAILIES Total 1
Daily disposable soft contact lens to be worn at least 8 hours daily
narafilcon ADevice
Also called 1-Day ACUVUE TruEye
Daily disposable contact lens to be worn at least 8 hours daily
| Study group | Role | What they receive |
|---|---|---|
| delefilcon A | Active comparator | Spherical daily disposable soft contact lens Receives: Device: delefilcon A |
| narafilcon A | Experimental | Spherical daily disposable soft contact lens Class 1 UV blocking Receives: Device: narafilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Ease of Lens Removal
After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013
- Study completionAug 2013
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 Refractive ErrorStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 279 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
- NCT01875471
- Sponsor's protocol ID
- CR-5305
- Status last verified
- May 2016
- First submitted
- 7 Jun 2013
- 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
- Clinical Evaluation of Two Daily Disposable Contact Lenses
- ClinicalTrials.gov ID
- NCT01875471
- Acronym / sponsor ID
- CR-5305
- Conditions
- Refractive Error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Posted 4 Jun 2015
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 compare the ease of removing two daily disposable soft contact lenses off the eye.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delefilcon A | Active comparator | Device: delefilcon ASpherical daily disposable soft contact lens |
| narafilcon A | Experimental | Device: narafilcon ASpherical daily disposable soft contact lens Class 1 UV blocking |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The subject must be between 18 and 45 years of age (inclusive)with no presbyopic add.
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).
- The subject must be willing to wear the study lenses for at least 8 hours per day, at least 6 days between visits.
- The subject must be a current successful spherical soft contact lens wearer in both eyes.
- The subject must appear willing and able to adhere to the instructions set forth in this clinical protocol.
Key exclusion criteria (14 listed)
- 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.
- Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or infiltrates 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 ocular infection.
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 |
|---|---|---|
| delefilcon AAlso: DAILIES Total 1Daily disposable soft contact lens to be worn at least 8 hours daily | Device | delefilcon A |
| narafilcon AAlso: 1-Day ACUVUE TruEyeDaily disposable contact lens to be worn at least 8 hours daily | Device | narafilcon A |
Primary outcome
Subjective Ease of Lens Removal
Time frame: Day 7
After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).
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.
Related trials for Refractive Error
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing delefilcon A and narafilcon A in people with Refractive Error, run by Johnson & Johnson Vision Care, Inc. at 11 sites in United Kingdom.
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 9 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 11 sites in United Kingdom. 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 4 Jun 2015). 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 Ease of Lens Removal (time frame: Day 7). 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.