Clinical Characterization of Symptomatic Populations

Johnson & Johnson (J&J)

Status: Completed

Conditions: Ametropia

Treatments: Device: senofilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT03319212

CR-5969

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

Active Comparator

Other group

Description:

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.

Treatment:

Device: senofilcon A contact lenses