- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02985827
Symptom Response in Normal and Dry Eye Patients Secondary to Application of a Menthol-Containing Eyedrop (Rohto® Hydra)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Rohto (r) Hydra
Menthol containing over the counter eyedrop
|
Rohto (r) Hydra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
Other Names:
Systane (r) Ultra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
Other Names:
|
Placebo Comparator: Systane (r) Ultra
Non-Menthol containing over the counter eyedrop
|
Rohto (r) Hydra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
Other Names:
Systane (r) Ultra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sum of the Cooling Scale For Rohto (r) Hydra
Time Frame: 4 Minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sum of the Cooling Scale For Systane (r) Ultra
Time Frame: 4 minutes
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Keith Lane, Ora Clinical
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Menthol FLIR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dry Eye
-
Gordon Schanzlin New VisionCompletedDry Eye | Dry Eye Disease | Evaporative Dry Eye | Kerato Conjunctivitis Sicca | Evaporative Dry Eye Disease | Dry Eye, EvaporativeUnited States
-
Kao (Taiwan) CorporationChang Gung Memorial HospitalCompletedEye Fatigue | Dry Eye SymptomTaiwan
-
Alcon ResearchCompletedVisual Performance | Dry Eye Symptoms
-
Alcon ResearchCompletedModerate to Severe Dry Eye
-
Singapore National Eye CentreCompleted
-
AllerganCompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
-
Senju Pharmaceutical Co., Ltd.CompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
-
Bausch & Lomb IncorporatedCompletedDry Eye Disease (DED)United States
-
Centre for Contact Lens ResearchCoopervision, Inc.CompletedContact Lens Related Dry EyeCanada
-
Singapore National Eye CentreCompleted
Clinical Trials on Rohto (r) Hydra
-
Vascular Innovations Co. Ltd.MedPass InternationalActive, not recruitingAortic Valve StenosisNew Zealand, Hong Kong, Thailand, Greece, Lithuania, Poland
-
University of WaterlooCompleted
-
The Mentholatum CompanyCompletedDry Eye | Dry Eye SyndromesUnited States
-
Sahajanand Medical Technologies LimitedClinica Di MontevergineRecruiting
-
Contamac LtdWithdrawn
-
Sahajanand Medical Technologies LimitedQmed Consulting A/SNot yet recruiting
-
M.D. Anderson Cancer CenterCancer Prevention Research Institute of TexasRecruitingSquamous Cell Carcinoma of the Larynx | Malignant Neoplasms of Respiratory and Intrathoracic OrgansUnited States
-
Joris B.W. ElbersErasmus Medical Center; HollandPTCRecruitingHead and Neck Squamous Cell Carcinoma | Radiotherapy | Proton Therapy | Hypofractionation | Immune System SuppressionNetherlands
-
Tangible ScienceUniversity of California, Davis; Nova Southeastern University; Illinois College...CompletedDry Eye | Dry Eye SyndromesUnited States
-
University of California, Los AngelesUniversity of Colorado, Denver; National Institute of Allergy and Infectious... and other collaboratorsCompletedRNA Virus Infections | Respiratory Tract Infections | Influenza, Human | Orthomyxoviridae Infections | Respiratory Tract Disease | Virus Disease | Physiological Effects of Drugs | VaccinesUnited States