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AmetropiaNCT03319212

Clinical Characterization of Symptomatic Populations

A study testing senofilcon A contact lenses in people with Ametropia, run by Johnson & Johnson Vision Care, Inc. at 2 sites in 2 countries.

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 an unmasked, non-randomized, single arm, stratified, dispensing investigation of symptomatic and asymptomatic subject populations. Subjects will be assigned to a single study lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear for 1 week. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Ametropia
What is being tested?
senofilcon A contact lenses
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
2 sitesin 2 countries
Study dates
29 Sep 2017to 15 Aug 2018
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, 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 55 (inclusive) years of age at the time of screening.
  • Be a current soft contact lens wearer in both eyes with a minimum of 3 days/week wear time over the last 1 month by self-report.
  • Have a baseline CLDEQ-8 score of either:
Show all 12Show fewer
  • 7 or lower
  • 15 or greater
  • Subjects must possess a functional / usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
  • Subjects must pass a pre-screening questionnaire.
  • Subjects must be willing to discontinue all contact lens wear for approximately 1 week/
  • Subjects must present to visit 1 with their habitual lenses on eye for at least 6 hours.

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 (at the discretion of the investigator).
  • Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
  • Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Show all 12Show fewer
  • Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
  • Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal
  • 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 (at the discretion of the investigator).

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • VRC-East

    Jacksonville, Florida, 32256

Other trials in United States

Canada1 site

  • University of Waterloo Center for Contact Lens Research

    Waterloo, Ontario

Other trials in Canada

About this study

This is an unmasked, non-randomized, single arm, stratified, dispensing investigation of symptomatic and asymptomatic subject populations. Subjects will be assigned to a single study lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear for 1 week.

Conditions
Ametropia
Being tested
senofilcon A contact lenses
Medical subject headings
Refractive Errors

What participants receive

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

  • senofilcon A contact lensesDevice

    Senofilcon A Daily Disposable Contact Lenses

Study groups in NCT03319212
Study groupRoleWhat they receive
Active ComparatorOtherSubjects that are between the ages 18-55 and are current spherical soft contact lens wearers will be assigned to a single study lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear for 1 week.
Receives: Device: senofilcon A contact lenses

What is being measured

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

  1. Meibomian Gland Imaging

    Meibomian gland imaging was assessed in each each subject eye, at baseline, 4-Week Follow-up (during lens wear) and the the 5-Week Follow-up on subjects' bare eyes. Meibomian gland imaging is expressed interms of area of loss using the following grading scale: Degree 0 ≈ 0%; Degree 1 ≤ 25%; Degree 2 26% - 50%; Degree 3 51% - 75%; Degree 4 ≥ 75%.

    Measured: 4-Week Follow-up

  2. Meibomian Gland Expressibility

    Meibomian glands were assessed in the three regions of each lower eyelid: temporal, central, and nasal. Approximately five glands are expressed per region with each use of the Meibomian Gland Evaluator. Secretions for each of the 5 glands selected within the three regions were graded using the following secretion grading scale: Grade 0 = No Secretion (Includes capped orifices), Grade 1 = Inspissated (semi-solid, toothpaste-like consistency), Grade 2 = Colored/Cloudy Liquid, Grade 3 = Clear Liquid Oil. The total grades for 5 glands per region was calculated for each subject. The total Meibomian Gland Secretion Score was calculated by adding the grades for the 15 glands assessed. Mean and standard deviation for total grade per region and total Meibomian Gland Secretion Score were reported for each stratum. Total scores range from 0 to 15 were lower score indicate worsening meibomian gland expressability.

    Measured: 4-Week Follow-up

  3. Lid Margin Evaluation: Number of Eyes With Abnormal Biomicroscopy Findings

    Lid margin evaluation was conducted for upper and lower lids for both left and right eyes. The presence of the following biomicroscopy findings were recorded as No/normal or Yes/abnormal:

    • Irregularity: Notching of Margin
    • Vascularity of Lid Margin: Telangiectasia
    • Meibomian Gland Pouting, Plugging, or Capping
    • Lid/Lash Margin Debris Findings.

    The number of positive findings (yes) was reported for each group.

    Measured: 4-Week Follow-up

  4. Lid Wiper Epitheliopathy

    Horizontal length of staining and sagittal width of staining were graded for both upper and lower lids for each eye. Average grade was calculated separately for upper and lower lids, and the final grade was calculated as the average grade across upper and lower lids. Mean and standard deviation were reported for the final grade by stratum. Subjects were classified according to their final lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Final Grades range from 0 to 3, where higher final grades indicate worsening lid wiper epitheliopathy.

    Measured: 4-Week Follow-up

  5. Conjunctival Folds

    Lid-parallel conjunctival folds (LIPCOF) will be evaluated in the area perpendicular to the temporal and nasal limbus on the bulbar conjunctiva above the lower lid (temporal and nasal LIPCOF, respectively), and classified using the LIPCOF grading scale: 0 = No conjunctival folds, 1 = One permanent and clear parallel fold, 2 = Two permanent and clear parallel folds (normally lower than 0.2mm), and 3 = More than two permanent and clear parallel folds (normally higher than 0.2mm).

    Measured: 4-Week Follow-up

Secondary outcomes (6)

  1. Conjunctival Redness

    Limbal and bulbar conjunctival redness were assessed or each quadrant (nasal, temporal, inferior, superior) using the following scale: 0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe.

    Measured: 4-Week Follow-up

  2. Conjunctival Staining

    Conjunctival staining was assessed for each eye by quadrant (Superior, Inferior, Nasal, Temporal) utilizing the following scale: Grade 0 = None (No conjunctival staining), Grade 1 = Trace (Scattered superficial punctate staining), Grade 2 = Mild (Regional or generalized punctate staining), Grade 3 = Moderate (Significant coalesced punctate staining), Grade 4 = Severe (Patch staining).

    Measured: 4-Week Follow-up

  3. Corneal Staining

    Corneal staining was assessed for each eye by region (Central, Superior, Inferior, Nasal, Temporal). Corneal staining type was evaluated using the following the scale: Grade 0 = None, Grade 1 = Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate, and Grade 4 = Patch (>1mm). Corneal staining area was evaluated using the following the scale: Grade 0 = 0% of region covered, Grade 1 = 10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4 = 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered, Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered, and Grade 10 = 100% of region covered. The following scale was used in the grading of corneal staining depth: Grade 0 = None, Grade 0 = Superficial epithelial, Grade 2 = Full epithelial, and Grade 3 = Stromal glow.

    Measured: 4-Week Follow-up

  4. Tear Film Lipid Layer Thickness

    Tear film lipid layer thickness was measured for each eye using LipiView II. The Review Lipid Images screen provided numerical analysis of the measured lipid layer thickness in nanometers (nm) from 10 (thinnest) to 240 (thickest), with a precision of 1 nm and an accuracy of 10 nm.

    Measured: 4-Week Follow-up

  5. Tear Film Stability

    Non-invasive tear break-up time (NIBUT) was measured for each eye to indicate the stability of the tear film. NIBUT is 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. Three measurements were taken on each eye. The average NIBUT was reported for each group.

    Measured: 4-Week Follow-up

  6. Tear Film Lipid Pattern

    Tear film lipid pattern was recorded for each eye using the following categories: None, Open Meshwork, Closed (Tight Meshwork), Flow (Wave), Amorphous, Colors, and Other.

    Measured: 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 posted24 Oct 2017
  2. Study start29 Sep 2017
  3. Primary completion15 Aug 2018
  4. Study completion15 Aug 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03319212
Sponsor's protocol ID
CR-5969
Status last verified
Oct 2019
First submitted
19 Oct 2017
Last updated
15 Oct 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 senofilcon A contact lenses in people with Ametropia, run by Johnson & Johnson Vision Care, Inc. at 2 sites in 2 countries.

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 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 15 Oct 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 States, 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 15 Oct 2019). 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?

Meibomian Gland Imaging (time frame: 4-Week Follow-up). The study lists 5 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 NCT03319212.

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 15 Oct 2019.

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