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

NCT02985827 | Completed Phase 4 Results

• 1 other identifier: Menthol FLIR
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sum of the Cooling Scale For Systane (r) Ultra

  4 minutes

Study Arms (2)

Rohto (r) Hydra

ACTIVE COMPARATOR

Menthol containing over the counter eyedrop

Drug: Rohto (r) Hydra; Drug: Systane (r) Ultra

Systane (r) Ultra

PLACEBO COMPARATOR

Non-Menthol containing over the counter eyedrop

Drug: Rohto (r) Hydra; Drug: Systane (r) Ultra

Interventions

Rohto (r) Hydra DRUG

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

Also known as: Rohto Hydra

Rohto (r) Hydra; Systane (r) Ultra

Systane (r) Ultra DRUG

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

Also known as: Systane Ultra

Rohto (r) Hydra; Systane (r) Ultra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ORA, Inc.: lead

Related Publications (1)

• 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.

  PMID: 28933582 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Senior Director of Research and Development
• Organization: Ora

klane@oraclinical.com

9786858900

Study Officials

• Keith Lane

  Ora Clinical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: December 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 27, 2023
• Results First Posted: December 19, 2018

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share