Clinical Characterization of Symptomatic Populations

NCT03319212 | Completed Results FDA Device

• 1 other identifier: CR-5969
• Study Type: interventional
• Target: 105
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Ametropia

Outcome Measures

Primary Outcomes (5)

• 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%.

  4-Week Follow-up

• 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.

  4-Week Follow-up

• 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.

  4-Week Follow-up

• 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.

  4-Week Follow-up

• 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).

  4-Week Follow-up

Secondary Outcomes (6)

• Conjunctival Redness

  4-Week Follow-up

• Conjunctival Staining

  4-Week Follow-up

• Corneal Staining

  4-Week Follow-up

• Tear Film Lipid Layer Thickness

  4-Week Follow-up

• Tear Film Stability

  4-Week Follow-up

Study Arms (1)

Active Comparator

OTHER

Subjects 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.

Device: senofilcon A contact lenses

Interventions

senofilcon A contact lenses DEVICE

Senofilcon A Daily Disposable Contact Lenses

Active Comparator

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• or lower
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (2)

VRC-East

Jacksonville, Florida, 32256, United States

Location

University of Waterloo Center for Contact Lens Research

Waterloo, Ontario, Canada

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Elizabeth Dow, OD, FAAO - Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care, Inc.

edow1@its.jnj.com

904-443-1061

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: September 29, 2017
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: October 15, 2019
• Results First Posted: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1)