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

Dry Eye Clinical Trial

Official title:

An Open-Label, Single-Center Study to Evaluate Symptom Response and Tear Film Cooling Dynamics of Normal and Dry Eye Patients Secondary to Application of a Menthol-Containing Eyedrop (Rohto® Hydra)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985827
• Other study ID #: Menthol FLIR
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: January 2016

Study information

• Verified date: December 2016
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Dry eye disease (DED) has been defined as a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface1. An estimated 25 million Americans are reported to have dry eye disease (DED)2, which is a number that will only increase with the U.S. aging population3. The only treatment currently available in the U.S. targets inflammation on the ocular surface. Because dry eye is a complicated disease that encompasses many conditions of the eye, diversified ways to treating the disease are necessary. Some recent studies suggests that some Dry Eye symptoms are caused by corneal cold thermoreceptors (such as TRPM8) chronically firing at below-normal thresholds. It thus logically follows that dry eye patients could be distinguished from normal patients by possessing higher symptom responses secondary to topical application of menthol, a potent agonist of TRPM8. If dry eye patients indeed have lower threshold firing of TRPM8, agonizing TRPM8 with menthol will elicit a more severe symptom response, given equal concentrations across populations. To fully elucidate this relationship between TRPM8 agonists, sensation, and tear film cooling, two dry eye populations will be tested - one population which has exhibited symptom response to a previous dry eye agent, and one population with no symptom response to the same agent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Rohto (r) Hydra
Rohto (r) Hydra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
• Systane (r) Ultra
Systane (r) Ultra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ORA, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of the Cooling Scale For Rohto (r) Hydra	Participants completed the cooling scale after receiving 1 dose of Rohto (r) Hydra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.	4 Minutes
Secondary	Sum of the Cooling Scale For Systane (r) Ultra	Participants completed the cooling scale after receiving 1 dose of Systane (r) Ultra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.	4 minutes