Clinical trial NCT03319212: Clinical Characterization of Symptomatic Populations
Official title: Clinical Characterization of Symptomatic Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-24
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Between 18 and 55 (inclusive) years of age at the time of screening.
  4. 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.
  5. Have a baseline CLDEQ-8 score of either:

     1. 7 or lower
     2. 15 or greater
  6. Subjects must possess a functional / usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
  7. Subjects must pass a pre-screening questionnaire.
  8. Subjects must be willing to discontinue all contact lens wear for approximately 1 week/
  9. Subjects must present to visit 1 with their habitual lenses on eye for at least 6 hours.

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or lactating, by self-report.
  2. Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
  3. Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
  4. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
  5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  6. Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
  7. Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal
  8. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
  9. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
  10. Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician).
  11. 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).

Primary outcomes:
measure: Meibomian Gland Imaging
timeFrame: 4-Week Follow-up
measure: Meibomian Gland Expressibility
timeFrame: 4-Week Follow-up
measure: Lid Margin Evaluation: Number of Eyes With Abnormal Biomicroscopy Findings
timeFrame: 4-Week Follow-up
measure: Lid Wiper Epitheliopathy
timeFrame: 4-Week Follow-up
measure: Conjunctival Folds
timeFrame: 4-Week Follow-up
Secondary outcomes:
measure: Conjunctival Redness
timeFrame: 4-Week Follow-up
measure: Conjunctival Staining
timeFrame: 4-Week Follow-up
measure: Corneal Staining
timeFrame: 4-Week Follow-up
measure: Tear Film Lipid Layer Thickness
timeFrame: 4-Week Follow-up
measure: Tear Film Stability
timeFrame: 4-Week Follow-up
measure: Tear Film Lipid Pattern
timeFrame: 4-Week Follow-up
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: VRC-East
state: Florida
city: Waterloo
country: Canada
facility: University of Waterloo Center for Contact Lens Research
state: Ontario
Study officials:
References: