Symptom Response in Normal and Dry Eye Patients Secondary to Application of a Menthol-Containing Eyedrop (Rohto® Hydra)
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Rohto (r) Hydra; Systane (r) Ultra
Intervention description: Rohto (r) Hydra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose; Systane (r) Ultra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to analyze the sensation to eye drops containing menthol in
      people with healthy eyes and in people with dry eyes. This study also examines the
      temperature of your eye using an Infrared Camera.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be male or female of any race, at least 18 years of age at Visit 1.

          2. Have provided verbal and written informed consent.

          3. Have a best corrected visual acuity of +0.70 logMAR or better in both eyes at Visit 1,
             as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.

          4. Qualify for exactly one of the three cohorts.

        Exclusion Criteria:

          1. Have any contraindications to the use of Systane® Ultra, or Rohto® Hyrda, or its
             components (including Menthol).

          2. Have a known allergy to the study medications or their components.

          3. Have any clinically significant slit lamp findings at Visit 1, including active
             blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or ocular
             allergies that requires therapeutic treatment and/or, in the opinion of the
             investigator, may interfere with the study parameters.

          4. Be diagnosed with an ongoing ocular infection (bacterial, viral or fungal), or active
             ocular inflammation (e.g., follicular conjunctivitis) at Visit 1.

          5. Have a history of laser in situ keratomileusis (LASIK) surgery in either eye.

          6. Have had any ocular surgical procedure within 12 months prior to Visit 1.

          7. Have used contact lenses within 30 days prior to Visit 1 and for the duration of the
             study.

          8. Have used any topical ocular prescription (including medications for glaucoma) or
             over-the-counter (OTC) solutions, artificial tear substitutes, gels or scrubs within
             24 hours prior to Visit 1 and for the duration of the study, except for the study
             drops.

          9. Have an uncontrolled systemic disease.

         10. Be a woman who is pregnant, nursing an infant, or planning a pregnancy.

         11. Have a condition or is in a situation that, in the opinion of the investigator, may
             put the patient at significant risk, may confound the study results, or may interfere
             significantly with the patients' participation in the study.

         12. Be currently enrolled in an investigational drug or device study or have used an
             investigational drug or device within 30 days prior to Visit 1.

         13. Currently have any punctal occlusions in either eye.