Clinical trial NCT03995355: Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients
Official title: Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-24
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-masked, randomized, bilateral, 2-Arm parallel group study. Subjects are scheduled for 3 study visits (screening/baseline, 7-Day and 30-Day follow-up visits) over a period of one month.


Eligibility criteria: Inclusion Criteria:

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

  1. Subjects must be at least 18 years of age and no more than 69 years of age (inclusive).
  2. Subjects must be non-contact lens wearers.
  3. Subjects must achieve visual acuity of 20/30 or better in each eye, either unaided or best corrected.
  4. Subjects must possess a functional/usable pair of spectacles and bring them to every visit (only if applicable - to the investigators discretion).
  5. Self-reported symptoms of ocular dryness or irritation and/or the use of artificial tears in the last 3 months.
  6. Subjects must read, understand, and sign the Statement of Informed Consent.
  7. Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol.

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

  1. Currently pregnant or breast-feeding.
  2. Diabetes.
  3. Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the investigator's discretion).
  4. Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the investigator's discretion).
  5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
  6. Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA scale.
  7. Any active ocular abnormalities/conditions that may interfere with the clinical trial (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc.).
  8. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.
  9. History of any ocular or corneal surgery (e.g. RK, PRK, LASIK).
  10. Participation in any pharmaceutical or medical device related clinical trial within 30 days prior to study enrollment.
  11. History of binocular vision abnormality or strabismus.
  12. Habitual wearers of soft contact lenses in the past 1 month or rigid gas permeable lens within the past 3 months.
  13. Current habitual use of Prescription Medicines to treat dry eye or ocular discomfort, ocular steroids, or any medication (RX or OTC) that would interfere with the clinical study (at the discretion of the investigator).
  14. Employees of investigational clinic (investigator, coordinator, and technician, etc.) or family member of an employee of the clinical site by self-report.

In addition to the above criteria, patients with any allergy or sensitivity to ingredients that this product may contain (Castor Oil, Polyoxyl 40 Hydrogenated Castor Oil, Sodium Chlorite, Boric Acid, Sodium Borate Decahydrate, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Polyethylene Glycol 400, Sodium Hyaluronate, Purified Water) should not participate in the study.

Primary outcomes:
measure: Change From Baseline Ocular Comfort (30-Day)
timeFrame: Baseline and 30-Day Follow-up
Secondary outcomes:
measure: Change From Baseline Ocular Comfort (7-Day)
timeFrame: Baseline and 7-Day Follow-up
measure: Number of Subject Eyes That Reported Ocular Symptoms
timeFrame: 7-Day Follow-up and 30-Day Follow-up
measure: Number of Subject Eyes That Experience Grade 2 or Higher Corneal Staining
timeFrame: 7-Day Follow-up and 30-Day Follow-up
measure: Change From Baseline Ocular Vision (7-Day)
timeFrame: Baseline and 7 Day-Day Follow-up
measure: Change From Baseline Ocular Vision (30-Day)
timeFrame: Baseline and 30 Day Follow-up
Other outcomes:
Locations:
city: Amarillo
country: United States
facility: Premier Vision
state: Texas
Study officials:
References: