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Visual AcuityNCT02756078

Clinical Performance Evaluation of Two Silicone Hydrogel Lenses

A study testing TEST Contact Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in Canada.

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 is a randomized, double-masked dispensing study where subjects will randomized into one of two lens sequences to wear each of two contact lens types for a 4-week period with each lens type. 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?
TEST Contact Lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteCanada
Study dates
8 Apr 2016to 2 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 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 appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • 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 -0.50 Diopters (D) to -8.00 D in each eye.
  • The subject's refractive cylinder must be no more than -1.00 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.
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  • 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.
  • The subject must be using digital devices (any combination of computers, tablets, smart phones 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 a subject 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.
  • Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (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 vision abnormality or strabismus.
  • Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Contact Lens Research, University of Waterloo

    Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

This is a randomized, double-masked dispensing study where subjects will randomized into one of two lens sequences to wear each of two contact lens types for a 4-week period with each lens type.

Conditions
Visual Acuity
Being tested
TEST Contact Lens, CONTROL Contact Lens

What participants receive

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

  • TEST Contact LensDevice

    Also called senofilcon A

  • CONTROL Contact LensDevice

    Also called samfilcon A

Study groups in NCT02756078
Study groupRoleWhat they receive
Group 1 (TEST / CONTROL wear sequence)Active comparatorSubjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the TEST / CONTROL wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.
Receives: Device: TEST Contact Lens; Device: CONTROL Contact Lens
Group 2 (CONTROL / TEST wear sequence)Active comparatorSubjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the CONTROL / TEST wearing sequence will wear each of the study lenses for 4 weeks according to the manufacturer's guidelines. Subjects will be dispensed the other (second) lens type at the second dispense visit.
Receives: Device: TEST Contact Lens; Device: CONTROL Contact Lens

What is being measured

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

  1. Overall CLUE Comfort

    Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. 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 with a range of 0-120.

    Measured: Up to 4-Week Follow-up

Secondary outcomes (6)

  1. Overall CLUE Handling

    Overall Handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. 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 with a range of 0-120.

    Measured: Up to 4-Week Follow-up

  2. Time to Haze

    Time to haze measure the maximum time a contact lens wearers can keep their eye open without their vision becoming hazy. It was a measure of how the drying of the contact lens surface with open eyes affects vision.

    Measured: Up to 4-Week Follow-up

  3. Average Wear Time

    Average lens wear time with the study lenses were recorded in hour at each follow-up visit.

    Measured: Up to 4-Week Follow-up

  4. Average Comfortable Wear Time

    Average comfortable lens wear time with the study lenses were recorded in hour at each follow-up visit.

    Measured: Up to 4-Week Follow-up

  5. Difference in Total Device Use Time and Comfortable Wear Time During Device Use

    Subjects reported the total duration of their digital device use and comfortable lens wear time during digital device use.

    Measured: Up to 4-Week Follow-up

  6. Comfort at the End of the Day

    Subjects graded the comfort level at the end of the day using 5- point scale (1=excellence, 2=very good, 3=good, 4=fair and 5=poor). The average end of day comfort grade was reported for each lens type.

    Measured: Up to 4-Week Follow-up

Timeline

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

  1. First posted29 Apr 2016 (estimated)
  2. Study start8 Apr 2016
  3. Primary completion2 Oct 2017
  4. Study completion2 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
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02756078
Sponsor's protocol ID
CR-5816
Status last verified
Oct 2018
First submitted
26 Apr 2016
Last updated
14 Nov 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing TEST Contact Lens in people with Visual Acuity, 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 12 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 14 Nov 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 Oct 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 CLUE Comfort (time frame: Up to 4-Week Follow-up). 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 NCT02756078.

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 14 Nov 2018.

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