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

Primary Purpose

Dry Eye

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Rohto (r) Hydra

Systane (r) Ultra

About this trial

This is an interventional basic science trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Be male or female of any race, at least 18 years of age at Visit 1.
Have provided verbal and written informed consent.
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.
Qualify for exactly one of the three cohorts.

Exclusion Criteria:

Have any contraindications to the use of Systane® Ultra, or Rohto® Hyrda, or its components (including Menthol).
Have a known allergy to the study medications or their components.
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.
Be diagnosed with an ongoing ocular infection (bacterial, viral or fungal), or active ocular inflammation (e.g., follicular conjunctivitis) at Visit 1.
Have a history of laser in situ keratomileusis (LASIK) surgery in either eye.
Have had any ocular surgical procedure within 12 months prior to Visit 1.
Have used contact lenses within 30 days prior to Visit 1 and for the duration of the study.
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.
Have an uncontrolled systemic disease.
Be a woman who is pregnant, nursing an infant, or planning a pregnancy.
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.
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.
Currently have any punctal occlusions in either eye.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rohto (r) Hydra

Systane (r) Ultra

Arm Description

Menthol containing over the counter eyedrop

Non-Menthol containing over the counter eyedrop

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02985827

First Posted

December 5, 2016

Last Updated

June 23, 2023

Sponsor

ORA, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02985827

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ORA, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rohto (r) Hydra

Arm Type

Active Comparator

Arm Description

Menthol containing over the counter eyedrop

Arm Title

Systane (r) Ultra

Arm Type

Placebo Comparator

Arm Description

Non-Menthol containing over the counter eyedrop

Intervention Type

Drug

Intervention Name(s)

Rohto (r) Hydra

Other Intervention Name(s)

Rohto Hydra

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Systane (r) Ultra

Other Intervention Name(s)

Systane Ultra

Intervention Description

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

Primary Outcome Measure Information:

Title

Sum of the Cooling Scale For Rohto (r) Hydra

Description

Time Frame

4 Minutes

Secondary Outcome Measure Information:

Title

Sum of the Cooling Scale For Systane (r) Ultra

Description

Time Frame

4 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be male or female of any race, at least 18 years of age at Visit 1. Have provided verbal and written informed consent. 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. Qualify for exactly one of the three cohorts. Exclusion Criteria: Have any contraindications to the use of Systane® Ultra, or Rohto® Hyrda, or its components (including Menthol). Have a known allergy to the study medications or their components. 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. Be diagnosed with an ongoing ocular infection (bacterial, viral or fungal), or active ocular inflammation (e.g., follicular conjunctivitis) at Visit 1. Have a history of laser in situ keratomileusis (LASIK) surgery in either eye. Have had any ocular surgical procedure within 12 months prior to Visit 1. Have used contact lenses within 30 days prior to Visit 1 and for the duration of the study. 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. Have an uncontrolled systemic disease. Be a woman who is pregnant, nursing an infant, or planning a pregnancy. 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. 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. Currently have any punctal occlusions in either eye.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Keith Lane

Organizational Affiliation

Ora Clinical

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28933582

Citation

Corcoran P, Hollander DA, Ousler GW 3rd, Angjeli E, Rimmer D, Lane K, Abelson MB. Dynamic Sensitivity of Corneal TRPM8 Receptors to Menthol Instillation in Dry Eye Versus Normal Subjects. J Ocul Pharmacol Ther. 2017 Nov;33(9):686-692. doi: 10.1089/jop.2017.0050. Epub 2017 Sep 21.

Results Reference

derived

Learn more about this trial

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

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