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Visual AcuityNCT03139578

Short-Term Clinical Comparison of Two Silicone Hydrogel Daily Disposable Contact Lenses

A study testing Test 8.5BC and Test 9.0BC in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be a 2 period one-day, double-masked, randomized, repeated measures, non-dispensing, cross-over study where the main purpose of this study is to compare the performance of a new daily disposable silicone hydrogel lens with that of an existing similar lens. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Visual Acuity
What is being tested?
Test 8.5BC and Test 9.0BC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
2 sitesUnited Kingdom
Study dates
28 Apr 2017to 22 Oct 2017
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:
  • The subject must read and sign the Informed Consent form.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • Healthy adult males or females aged 18-55 years.
  • The subject's spherical contact lens requirement in the range +2.00 D to +4.00 D or -1.00 D to -6.00 D.
  • The subject's refractive cylinder must be ≤1.00 D in each eye.
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  • The subject must have visual acuity best correctable to 6/9 (20/30) or better for each eye.
  • The subject is a current soft contact lens wearer (defined as a minimum of 6 hours of DW per day, at least 5 days per week, for a minimum of 1 month prior to the study).
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Who cannot join

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:
  • Currently pregnant or lactating
  • Any systemic disease (e.g., Sjögren's Syndrome),allergies, infectious disease (e.g., hepatitis,tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
  • Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
  • Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
  • Extended wear contact lens correction.
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  • Any current use of ocular medication.
  • Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
  • Any greater than Grade 2 slit lamp findings (e.g., oedema, corneal neovascularisation, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale or any other ocular abnormality that may contraindicate contact lens wear.
  • Any contact lens-related history or signs of a corneal inflammatory event, or any other ocular abnormality that would contraindicate contact lens wear.
  • Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment.
  • Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Aston University Optometry and Vision Science

    Birmingham

  • Visioncare Research

    Farnham

Other trials in United Kingdom

About this study

This will be a 2 period one-day, double-masked, randomized, repeated measures, non-dispensing, cross-over study where the main purpose of this study is to compare the performance of a new daily disposable silicone hydrogel lens with that of an existing similar lens.

Conditions
Visual Acuity
Being tested
Test 8.5BC, Test 9.0BC, Control 8.5BC, Control 9.0BC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test 8.5BCDevice

    senofilcon A contact lenses with 8.5 base curve

  • Test 9.0BCDevice

    senofilcon A contact lenses with 9.0 base curve

  • Control 8.5BCDevice

    narafilcon A contact lenses with 8.5 base curve

  • Control 9.0BCDevice

    narafilcon A contact lenses with 9.0 base curve

Study groups in NCT03139578
Study groupRoleWhat they receive
C 8.5\C 9.0\T 8.5\T 9.0ExperimentalSubjects randomized to this sequence received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
Receives: Device: Test 8.5BC; Device: Test 9.0BC; Device: Control 8.5BC; Device: Control 9.0BC
C 9.0\C 8.5\T 9.0\T 8.5ExperimentalSubjects randomized to this sequence received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
Receives: Device: Test 8.5BC; Device: Test 9.0BC; Device: Control 8.5BC; Device: Control 9.0BC
T 8.5\T 9.0\C 8.5\C 9.0ExperimentalSubjects randomized to this sequence received Test lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the first period and then received Control lens (base curve 8.5 on the left eye and 9.0 on the right eye) during the second period.
Receives: Device: Test 8.5BC; Device: Test 9.0BC; Device: Control 8.5BC; Device: Control 9.0BC
T 9.0\T 8.5\C 9.0\C 8.5ExperimentalSubjects randomized to this sequence received Test lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the first period and then received Control lens (base curve 9.0 on the left eye and 8.5 on the right eye) during the second period.
Receives: Device: Test 8.5BC; Device: Test 9.0BC; Device: Control 8.5BC; Device: Control 9.0BC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Fit Acceptance

    Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported.

    Measured: 30-45 minutes after lens settling

  2. Lens Power Requirement

    The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control).

    Measured: 30-45 minutes after lens settling

Secondary outcomes (5)

  1. Subjective Comfort at Lens Insertion

    Subjective comfort on insertion was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.

    Measured: Immediately upon lens insertion

  2. Subjective Comfort After Lens Settling

    Subjective comfort on setting was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.

    Measured: 30-45 minutes after lens settling

  3. Subjective Vision Quality

    Subjective vision quality was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely blurred and 10=perfect. The score ranges from 0 to 10, where higher scores indicate better vision quality. The average vision quality score for each lens was reported.

    Measured: 30-45 minutes after lens settling

  4. Subjective Handling

    Subjective handling was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely difficult and 10=very easy. The score ranges from 0 to 10, where higher scores indicate better handling. The average handling score for each lens was reported.

    Measured: Immediately upon lens insertion

  5. Monocular High Contrast Visual Acuity (VA)

    Monocular high contrast distance VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type.

    Measured: 30-45 minutes after lens settling

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2017
  2. Study start28 Apr 2017
  3. Primary completion22 Oct 2017
  4. Study completion22 Oct 2017

Resources

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
Model description
Contra-lateral Assignment
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03139578
Sponsor's protocol ID
CR-5932
Status last verified
Jan 2019
First submitted
2 May 2017
Last updated
1 Feb 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Test 8.5BC and Test 9.0BC in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 2 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 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 1 Feb 2019. 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 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 11 Dec 2018). 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?

Overall Fit Acceptance (time frame: 30-45 minutes after lens settling). 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?

On the ClinicalTrials.gov record for NCT03139578.

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 1 Feb 2019.

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