Dry EyePhase 4NCT02985827
Symptom Response in Normal and Dry Eye Patients Secondary to Application of a Menthol-Containing Eyedrop (Rohto® Hydra)
A Phase 4 study testing Rohto (r) Hydra and Systane (r) Ultra in people with Dry Eye, run by ORA, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Rohto (r) Hydra and Systane (r) Ultra
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jan 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
About this study
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)
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.
Read the 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.
- Conditions
- Dry Eye
- Being tested
- Rohto (r) Hydra, Systane (r) Ultra
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rohto (r) HydraDrug
Also called Rohto Hydra
Rohto (r) Hydra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
Systane (r) UltraDrug
Also called Systane Ultra
Systane (r) Ultra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
| Study group | Role | What they receive |
|---|---|---|
| Rohto (r) Hydra | Active comparator | Menthol containing over the counter eyedrop Receives: Drug: Rohto (r) Hydra; Drug: Systane (r) Ultra |
| Systane (r) Ultra | Placebo comparator | Non-Menthol containing over the counter eyedrop Receives: Drug: Rohto (r) Hydra; Drug: Systane (r) Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 Minutes
Secondary outcomes (1)
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.
Measured: 4 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Lane, Study director, Ora Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985827
- Sponsor's protocol ID
- Menthol FLIR
- Status last verified
- Dec 2016
- First submitted
- 5 Dec 2016
- Last updated
- 27 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28933582
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02985827
- Acronym / sponsor ID
- Menthol FLIR
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Posted 19 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rohto (r) Hydra | Active comparator | Drug: Rohto (r) Hydra, Drug: Systane (r) UltraMenthol containing over the counter eyedrop |
| Systane (r) Ultra | Placebo comparator | Drug: Rohto (r) Hydra, Drug: Systane (r) UltraNon-Menthol containing over the counter eyedrop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rohto (r) HydraAlso: Rohto HydraRohto (r) Hydra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose | Drug | Rohto (r) Hydra, Systane (r) Ultra |
| Systane (r) UltraAlso: Systane UltraSystane (r) Ultra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose | Drug | Rohto (r) Hydra, Systane (r) Ultra |
Primary outcome
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.
1 secondary outcome
Sum of the Cooling Scale For Systane (r) Ultra
Time frame: 4 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28933582Corcoran 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Lane study director
Ora Clinical
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rohto (r) Hydra and Systane (r) Ultra in people with Dry Eye, run by ORA, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of the Cooling Scale For Rohto (r) Hydra (time frame: 4 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02985827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.