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Visual AcuityNCT03913377

Ocular Characteristics in Contact Lens and Spectacle Wear

A study testing Spectacles and ACUVUE OASYS®1-Day with HydraLuxe™ Technology in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 3 sites in United States.

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 clinical study will investigate the difference in ocular characteristics between contact lens wear and spectacle wear among habitual contact lens wearers, using a 2-treatment by 2-period cross-over design. There will be a 1-week washout between the two study periods to eliminate any potential carryover effect. Read more about this study

Who is it for?
Ages 18 to 42 yearsHealthy volunteers can take part
Conditions the study is for
Visual Acuity
What is being tested?
Spectacles and ACUVUE OASYS®1-Day with HydraLuxe™ Technology
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
3 sitesUnited States
Study dates
9 Apr 2019to 14 Jun 2019
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 42 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 will have completed the pre-screening Classification questionnaire.
  • Subject must have a working cell phone capable of sending and receiving text messages.
  • The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  • Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • Between 18 and 42 (inclusive) years of age at the time of screening
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  • Be a current soft contact lens wearer in both eyes with a minimum of 5 days/week wear time over the last 1 month by self-report OR be a full-time spectacle wearer (7 days/ week) without contact lens wear over the last 6 months.
  • Subjects must be willing to adhere to spectacle-only refractive correction for approximately 1 week.
  • Subjects must possess a functional / usable pair of spectacles with which they can achieve 20/20 Snellen visual acuity or better at distance and near, and bring them to the visit
  • The subject's vertex corrected spherical distance refraction must be in the range (+/-0.25 D) of -2.00 D to -6.00 D (inclusive) in each eye.
  • The subject's vertex corrected refractive cylinder must be equal or less than -0.75 diopters in each eye.
  • Contact lens wearers must have spherical best corrected visual acuity of 20/25 or better in each eye.
  • Snellen visual acuity at distance and near must be within 1 line between subject's own spectacle and the manifest refraction, distance and near, OD \& OS.

Who cannot join

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:
  • Currently pregnant or lactating, by self-report
  • Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator).
  • Any active ocular abnormalities/conditions that may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator).
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear
  • Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
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  • Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal
  • Habitual spectacle contains an add power, photochromic or tint.
  • Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
  • Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
  • Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician)
  • Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator)
  • 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.
  • Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale (CTP-2018).
  • Accommodative/binocular dysfunction, determined by study procedures.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • VRC-East

    Jacksonville, Florida, 32256

  • Sabal Eye Care

    Longwood, Florida, 32779

  • Manhattan Vision Associates

    New York, New York, 10022

Other trials in United States

About this study

This clinical study will investigate the difference in ocular characteristics between contact lens wear and spectacle wear among habitual contact lens wearers, using a 2-treatment by 2-period cross-over design. There will be a 1-week washout between the two study periods to eliminate any potential carryover effect.

Conditions
Visual Acuity
Being tested
Spectacles, ACUVUE OASYS®1-Day with HydraLuxe™ Technology

What participants receive

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

  • SpectaclesDevice

    Subjects' own habitual spectacles

  • ACUVUE OASYS®1-Day with HydraLuxe™ TechnologyDevice

    Test 1

Study groups in NCT03913377
Study groupRoleWhat they receive
ObservationalExperimentalEligible subjects that are habitual spectacle wearers will use their habitual optical correction and undergo ocular evaluations and questionnaires at the baseline and 1-week visit.
Receives: Device: Spectacles
InterventionalExperimentalEligible subjects that are habitual contact lens wearers who own spectacles will be randomized into 1 of 2 sequences (Spectacle/ACUVUE OASYS 1-Day or ACUVUE OASYS 1-Day/Spectacle)
Receives: Device: Spectacles; Device: ACUVUE OASYS®1-Day with HydraLuxe™ Technology

What is being measured

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

  1. Non-Invasive Break Up Time (NIBUT) or Non-Invasive Keratograph Break Up Time (NIKBUT)

    NIBUT/NIKBUT was measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort. NIBUT is measured by a topographer (e.g. Medmont) via observation by the investigator and a stopwatch. NIKBUTis measured by the Oculus Keratograph and reported by the instrument. Different instrumentation was used depending on site availability. Combined measurements of pre-lens data collected for the interventional arm are reported. Only the interventional arm was reported since the primary analysis was conducted among habitual contact lens users. The average NIKBUT was reported for each treatment. Higher values indicate better performance

    Measured: 1-Week Follow-up

Secondary outcomes (4)

  1. Total Scores of Meibomian Gland Expressibility (MGE)

    Meibomian gland expressiblity was assessed in three regions of the lower eyelid: temporal, central, and nasal. Each region is expressed and the overall grade of the region is evaluated using a four-grade scale: 0 = No Secretion, 1 = Inspissated, 2 = Colored/Cloudy Liquid, and 3 = Clear Liquid Oil. The total score was calculated as the sum of all grades across the three regions and ranged from 0 (no secretion) to 9, with higher scores indicating more MGE. Total scores were converted into a binary variable for the analysis purpose where Y=1 if the total score is greater than 6 and 0 otherwise. The percentage of participants with MGE total score greater than 6 was estimated. Only the interventional arm was reported since the secondary analysis was conducted among habitual contact lens users.

    Measured: 1-Week Follow-up

  2. Conjunctival Staining

    Conjunctival staining was graded and recorded by quadrant (Superior, Inferior, Nasal, and Temporal) using the following grading scale: Grade 0 = None, Grade 1 = Trace, Grade 2 = Mild, Grade 3 = Moderate, and Grade 4 = Severe. Average grade was calculated based on grades of the four quadrants. Only the interventional arm was reported since the secondary analysis was conducted among habitual contact lens users.

    Measured: 1-Week Follow-up

  3. Number of Eyes With Clinically Significant (Grade 3 or 4 of Overall Classification) Lid Wiper Epitheliopathy

    Horizontal lid margin staining and sagittal lid margin staining are graded for each eyelid (upper and lower) separately. The horizontal and sagittal grades are then averaged for each eyelid to obtain the upper lid average grade and lower lid average grade. The final grade is the average of the upper and lower lid average grades. Participants can be classified according to their final grades for each eye. The classification is defined as follows: "None" for final grades of 0, "Mild" for final grades between 0.25 and 1.00, "Moderate" for final grades between 1.25 and 2.00, and "Severe" for final graded between 2.25 and 3.00. Only the interventional arm was reported since the secondary analysis was planned to be conducted among habitual contact lens users only.

    Measured: 1-Week Follow-up

  4. Meibomian Gland Expressibility (MGE) Grades

    Meibomian gland expressiblity was assessed in three regions of the lower eyelid: temporal, central, and nasal. Each region is expressed and the overall grade of the region is evaluated using a four-grade scale: 0 = No Secretion, 1 = Inspissated, 2 = Colored/Cloudy Liquid, and 3 = Clear Liquid Oil. Only the interventional arm was reported since the secondary analysis was conducted among habitual contact lens users.

    Measured: 1-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 posted12 Apr 2019
  2. Study start9 Apr 2019
  3. Primary completion14 Jun 2019
  4. Study completion14 Jun 2019

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
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03913377
Sponsor's protocol ID
CR-6332
Status last verified
Jan 2021
First submitted
10 Apr 2019
Last updated
4 Feb 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A study testing Spectacles and ACUVUE OASYS®1-Day with HydraLuxe™ Technology in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 3 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 13 inclusion and 15 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 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2020). 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?

Non-Invasive Break Up Time (NIBUT) or Non-Invasive Keratograph Break Up Time (NIKBUT) (time frame: 1-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 NCT03913377.

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 4 Feb 2021.

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