Comparison of Tear Evaporation Rate With Systane Complete in Dry Eye and Non-Dry Eye
Condition: Evaporative Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Systane Complete
Intervention description: Systane Complete will be instilled and rate of evaporation assessed before and after.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to compare the rate of tear evaporation, measured with a novel
      evaporimeter, before and for one hour after an eye drop containing nano-sized oil droplets
      has been instilled.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is at least 18 years of age and has full legal capacity to volunteer;

          2. Has read and signed an information consent letter;

          3. Is willing and able to follow instructions and maintain the appointment schedule;

          4. Is willing to be awake for at least 2 hours before visit 2;

          5. Is willing not to wear eye makeup on the day of visit 2;

          6. Is willing not to use eye drops or artificial tears on the days of visits 1 or 2;

          7. Group specific criteria:

               1. Dry eye participant group: Symptoms: OSDI ≥ 13 and Signs: NIKBUT ≤ 5 s in the
                  worst eye

               2. Non-dry eye participant group: Symptoms: OSDI < 13 and Signs: NIKBUT ≥ 10 s in
                  the worst eye

        Exclusion Criteria:

          1. Is participating in any concurrent clinical or research study;

          2. Has any known active* ocular disease and/or infection;

          3. Has a systemic condition that in the opinion of the investigator may affect a study
             outcome variable;

          4. Is using any systemic or topical medications that in the opinion of the investigator
             may affect a study outcome variable;

          5. Has known sensitivity to sodium fluorescein dye;

          6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal
             confirmation at the screening visit);

          7. Is aphakic;

          8. Has undergone refractive error surgery;

          9. Has undergone ocular surgery in the last 6 months;

         10. Has punctal plugs;

         11. Has a known sensitivity to Systane eye drops (including Systane Balance, Systane
             Complete, Systane Gel Drops, Systane Ultra, etc.)

         12. Has a known sensitivity to petroleum jelly (Vaseline);

         13. Has epilepsy and/or sensitivity to flashing lights;

         14. Has worn contact lenses within the past month or is planning to wear contact lenses
             during the study;

         15. Has any physical impairment that would interfere with holding the evaporimeter;

         16. Has taken part in another clinical research study involving ocular drops or treatments
             within the last 14 days; * For the purposes of this study, active ocular disease is
             defined as infection or inflammation which requires therapeutic treatment. Mild (i.e.
             not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland
             dysfunction, papillae), corneal and conjunctival staining and dry eye are not
             considered active ocular disease. Neovascularization and corneal scars are the result
             of previous hypoxia, infection or inflammation and are therefore not active.