Clinical Evaluation of Etafilcon A With Ketotifen

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 2

Conditions: Visual Acuity

Treatments: Combination Product: etafilcon A with ketotifen; Device: 1-Day ACUVUE

Study type: Interventional

Funder types: Industry

Identifiers

NCT03388138

CR-5930

Details and patient eligibility

About

This clinical study is a randomized, double-masked, bilateral, controlled, two-arm parallel group, multi-site, 1-Week, 2-visit dispensing study. Subjects between the ages of 18-40 will be randomized into a placebo arm or an investigational K-Lens arm.

Enrollment: 143 patients

Sex: All

Ages: 18 to 40 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 39 (inclusive) years of age at the time of baseline visit.

  4. The subject must be a habitual lens wearer for a least 6 days/week and for a minimum of 8 hours per day over the last month.

  5. The subject's contact lens correction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.

  6. The subject's refractive cylinder must be 1.00 D or less in each eye.

  7. Have a spherocylindrical best corrected visual acuity of 20/30 or better in each eye (Snellen Visual Acuity).

     Exclusion Criteria:

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

  1. Currently pregnant or lactating.
  2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
  3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear.
  4. 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.
  5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear, history of strabismus, or current monovision, multi-focal, or toric contact lens correction.
  6. Any current use of rewetting drops or ocular medication.
  7. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  8. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Biomicroscopy Scale.
  9. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear.
  10. Any known hypersensitivity or allergic reaction to ketotifen.
  11. Participation in any eye drop, contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  12. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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143 participants in 2 patient groups, including a placebo group

K-Lens

Active Comparator group

Description:

etafilcon A with ketotifen. Subjects between the ages of 18-40 will be randomized into the K-Lens arm and will be scheduled for a total of two study visits with approximately 6-9 days in between.

Treatment:

Combination Product: etafilcon A with ketotifen

Placebo Contact Lens

Placebo Comparator group

Description:

1-Day Acuvue. Subjects between the ages of 18-40 will be randomized into the Placebo arm and will be scheduled for a total of two study visits with approximately 6-9 days in between.

Treatment:

Device: 1-Day ACUVUE