Clinical Evaluation of Two Marketed Artificial Tears in Non-contact Lens Wearing Patients
Condition: Visual Acuity
Intervention: Test Eye Drops; Control Eye Drops
Intervention description: blink® intensive TRIPLE ACTION 3 in 1 eye drops; Systane® BALANCE eye drops
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This clinical study is a randomized, double-masked, cross-over, bilateral, 2 treatment x 2
      period, dispensing 4-visit study with a 7-9 day washout period in between visits 2 and 3. The
      study will last approximately 3 months.
    

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 have a DEQ-5 score of >6 at either Visit 0 (pre-screen) and/or
                  Visit 1 (screening).

               4. Subjects must achieve visual acuity of 20/30 (equivalent to 0.18 logMAR) or
                  better in each eye, either unaided or best corrected.

               5. Subjects must possess a functional/usable pair of spectacles and bring them to
                  every visit (only if applicable - to the investigators discretion).

               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 14 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 Only Medicines (POM) 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 (liposomes, sodium hyaluronate, vitamin E polyethylene glycol
        succinate (TPGS), polyethylene glycol 400 (PEG 400), disodium edetate, polyhexanide
        methylbiguanide, propylene glycol, boric acid, dimyristoyl phosphatidylglycerol, edetate
        disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 sterate, polyquaternium-1, sorbitan
        tristearate, sorbitol, hydrochloric acid and/or sodium hydroxide) should not participate in
        the study.