Symptom Response in Normal and Dry Eye Patients Secondary to Application of a Menthol-Containing Eyedrop (Rohto® Hydra)

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ORA, Inc.
• Treatments: Menthol; Ophthalmic Solutions; Tetrahydrozoline

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.