Clinical trial NCT03388138: Clinical Evaluation of Etafilcon A With Ketotifen
Official title: Clinical Evaluation of Etafilcon A With Ketotifen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-02
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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 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).

Primary outcomes:
measure: Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population)
timeFrame: Baseline (Visit 1) and 1-week follow up (Visit 2)
measure: Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population)
timeFrame: Baseline (Visit 1) and 1-week follow up (Visit 2)
Secondary outcomes:
measure: The Number of Eyes With Clinically Significant Slit Lamp Findings
timeFrame: Up to 1-Week Follow-up
measure: The Number of Eyes With Unacceptable Lens Fitting
timeFrame: Up to 1-Week Follow-up
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Vue Optical Boutique
state: Florida
city: Maitland
country: United States
facility: Maitland Vision Center
state: Florida
city: Tampa
country: United States
facility: St. Lucy's Vision Center
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Salem
country: United States
facility: Botetourt Eyecare, LLC
state: Virginia
Study officials:
References: