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

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ClinicalTrials.gov Identifier: NCT02985827
Recruitment Status : Completed
First Posted : December 7, 2016
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
ORA, Inc.

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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Rohto (r) Hydra Drug: Systane (r) Ultra Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
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 Start Date : December 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Rohto (r) Hydra
Menthol containing over the counter eyedrop
Drug: Rohto (r) Hydra
Rohto (r) Hydra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
Other Name: Rohto Hydra

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

Placebo Comparator: Systane (r) Ultra
Non-Menthol containing over the counter eyedrop
Drug: Rohto (r) Hydra
Rohto (r) Hydra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
Other Name: Rohto Hydra

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985827


Sponsors and Collaborators
ORA, Inc.
Investigators
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Study Director: Keith Lane Ora Clinical
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT02985827    
Other Study ID Numbers: Menthol FLIR
First Posted: December 7, 2016    Key Record Dates
Results First Posted: December 19, 2018
Last Update Posted: December 19, 2018
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases