Dry EyeSPANIELNCT03987230
Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum
A study testing Sensitive Eyes® Plus Saline Solution, Oust™ Demodex® Wipes™ and I-LID N LASH PLUS® Eyelid Cleanser in people with Dry Eye, run by University of Waterloo at 1 site in Canada.
Trial summary
This aim of this study to quantify the subjective ocular awareness of different eyelid cleansing wipes available for the management of Demodex folliculorum. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Sensitive Eyes® Plus Saline Solution, Oust™ Demodex® Wipes™ and I-LID N LASH PLUS® Eyelid Cleanser
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2019to 18 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is between the ages of 18 to 60 and has the full legal capacity to volunteer;
- Has read and signed an informed consent letter;
- Agrees to refrain from the use of ocular lubricants during the study period;
- Agrees to not to use eye-related cosmetics for upcoming study visits
- Is willing to use the study products
- Is willing and able to follow instructions regarding study procedures and maintain the appointment schedule;
- Has corneal sensitivity within physiological limits.
Who cannot join
- Is participating in any concurrent clinical or research study;
- Is a contact lens wearer (due to reduced corneal sensitivity);
- Has any known active* ocular disease and/or infection; including moderate and severe dry eye (OSDI ≥ 23);
- Has a systemic (such as diabetes, thyroid disease, rheumatoid arthritis) or ocular condition (such as glaucoma) that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications (such as glaucoma drops, antibiotics, anti-inflammatory) that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study (such as fluorescein dye to highlight structures of the eye and used regularly in optometric practice) and study products in this study;
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- Is pregnant, lactating or planning a pregnancy at the time of enrolment; (due to the possibility of fluctuating vision as a consequence of variation in hormone levels);8
- Has undergone refractive error surgery (e.g. LASIK, PRK);
- Is a smoker (as smoking reduces tear film stability) * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye (Ocular Surface Disease Index, OSDI<23/100) are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Trial locations and contacts
1 site in 1 country.
About this study
This aim of this study to quantify the subjective ocular awareness of different eyelid cleansing wipes available for the management of Demodex folliculorum.
- Conditions
- Dry Eye
- Being tested
- Sensitive Eyes® Plus Saline Solution, Oust™ Demodex® Wipes™, I-LID N LASH PLUS® Eyelid Cleanser, Blephadex Lid Wipes, Eye Cleanse Lid Wipes
- 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.
Sensitive Eyes® Plus Saline SolutionDrug
Sensitive Eyes® Plus Saline Solution
Oust™ Demodex® Wipes™Other
Oust™ Demodex® Wipes™
I-LID N LASH PLUS® Eyelid CleanserOther
I-LID N LASH PLUS® Eyelid Cleanser
Blephadex Lid WipesOther
Blephadex Lid Wipes
Eye Cleanse Lid WipesOther
Eye Cleanse Lid Wipes
BlephademodexOther
Blephademodex
| Study group | Role | What they receive |
|---|---|---|
| Oust™ Demodex® Wipes™ | Active comparator | Participant cleans eyelids with Oust™ Demodex® Wipes™ Receives: Other: Oust™ Demodex® Wipes™ |
| I-LID N LASH PLUS® Eyelid Cleanser | Active comparator | Participant cleans eyelids with I-LID N LASH PLUS® Eyelid Cleanser Receives: Other: I-LID N LASH PLUS® Eyelid Cleanser |
| Blephadex Lid Wipes | Active comparator | Participant cleans eyelids with Blephadex Lid Wipes Receives: Other: Blephadex Lid Wipes |
| Eye Cleanse Lid Wipes | Active comparator | Participant cleans eyelids with Eye Cleanse Lid Wipes Receives: Other: Eye Cleanse Lid Wipes |
| Blephademodex | Active comparator | Participant cleans eyelids with Blephademodex Receives: Other: Blephademodex |
| Sensitive Eyes® Plus Saline Solution | Placebo comparator | Participant cleans eyelids with Sensitive Eyes® Plus Saline Solution Receives: Drug: Sensitive Eyes® Plus Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's Subjective discomfort - Baseline
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: Baseline
Participant's Subjective discomfort - 0 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: Immediately after application
Participant's Subjective discomfort - 15 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 15 seconds after application
Participant's Subjective discomfort - 30 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 30 seconds after application
Participant's Subjective discomfort - 45 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 45 seconds after application
Participant's Subjective discomfort - 60 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 60 seconds after application
Participant's Subjective discomfort - 75 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 75 seconds after application
Participant's Subjective discomfort - 90 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 90 seconds after application
Participant's Subjective discomfort - 105 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 105 seconds after application
Participant's Subjective discomfort - 120 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 120 seconds after application
Participant's Subjective discomfort - 135 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 135 seconds after application
Participant's Subjective discomfort - 150 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 150 seconds after application
Participant's Subjective discomfort - 165 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 165 seconds after application
Participant's Subjective discomfort - 180 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 180 seconds after application
Participant's Subjective discomfort - 195 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 195 seconds after application
Participant's Subjective discomfort - 210 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 210 seconds after application
Participant's Subjective discomfort - 225 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 225 seconds after application
Participant's Subjective discomfort - 240 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 240 seconds after application
Participant's Subjective discomfort - 255 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 255 seconds after application
Participant's Subjective discomfort - 270 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 270 seconds after application
Participant's Subjective discomfort - 285 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 285 seconds after application
Participant's Subjective discomfort - 300 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 300 seconds after application
Participant's Subjective discomfort - 330 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 330 seconds after application
Participant's Subjective discomfort - 360 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 360 seconds after application
Participant's Subjective discomfort - 390 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 390 seconds after application
Participant's Subjective discomfort - 420 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 420 seconds after application
Participant's Subjective discomfort - 450 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 450 seconds after application
Participant's Subjective discomfort - 480 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 480 seconds after application
Participant's Subjective discomfort - 510 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 510 seconds after application
Participant's Subjective discomfort - 540 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 540 seconds after application
Participant's Subjective discomfort - 570 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 570 seconds after application
Participant's Subjective discomfort - 600 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Measured: 600 seconds after application
Time to comfortably open the eyes after the application of eyelid cleansing wipe
Time to comfortably open the eyes after the application of eyelid cleansing wipe in seconds
Measured: Between 0 and 600 seconds after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start29 May 2019
- Primary completion18 Jun 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant receives 6 different interventions in random order
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987230
- Sponsor's protocol ID
- 40995
- Acronym
- SPANIEL
- Status last verified
- Jun 2019
- First submitted
- 5 Jun 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comfort Associated With The Use Of Eyelid Cleansing Products Available For The Management Of Demodex Folliculorum
- ClinicalTrials.gov ID
- NCT03987230
- Acronym / sponsor ID
- SPANIEL / 40995
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This aim of this study to quantify the subjective ocular awareness of different eyelid cleansing wipes available for the management of Demodex folliculorum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Each participant receives 6 different interventions in random order
| Arm | Type | Receives |
|---|---|---|
| Oust™ Demodex® Wipes™ | Active comparator | Other: Oust™ Demodex® Wipes™Participant cleans eyelids with Oust™ Demodex® Wipes™ |
| I-LID N LASH PLUS® Eyelid Cleanser | Active comparator | Other: I-LID N LASH PLUS® Eyelid CleanserParticipant cleans eyelids with I-LID N LASH PLUS® Eyelid Cleanser |
| Blephadex Lid Wipes | Active comparator | Other: Blephadex Lid WipesParticipant cleans eyelids with Blephadex Lid Wipes |
| Eye Cleanse Lid Wipes | Active comparator | Other: Eye Cleanse Lid WipesParticipant cleans eyelids with Eye Cleanse Lid Wipes |
| Blephademodex | Active comparator | Other: BlephademodexParticipant cleans eyelids with Blephademodex |
| Sensitive Eyes® Plus Saline Solution | Placebo comparator | Drug: Sensitive Eyes® Plus Saline SolutionParticipant cleans eyelids with Sensitive Eyes® Plus Saline Solution |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Is between the ages of 18 to 60 and has the full legal capacity to volunteer;
- Has read and signed an informed consent letter;
- Agrees to refrain from the use of ocular lubricants during the study period;
- Agrees to not to use eye-related cosmetics for upcoming study visits
- Is willing to use the study products
Key exclusion criteria (9 listed)
- Is participating in any concurrent clinical or research study;
- Is a contact lens wearer (due to reduced corneal sensitivity);
- Has any known active* ocular disease and/or infection; including moderate and severe dry eye (OSDI ≥ 23);
- Has a systemic (such as diabetes, thyroid disease, rheumatoid arthritis) or ocular condition (such as glaucoma) that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications (such as glaucoma drops, antibiotics, anti-inflammatory) that in the opinion of the investigator may affect a study outcome variable;
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 |
|---|---|---|
| Sensitive Eyes® Plus Saline SolutionSensitive Eyes® Plus Saline Solution | Drug | Sensitive Eyes® Plus Saline Solution |
| Oust™ Demodex® Wipes™Oust™ Demodex® Wipes™ | Other | Oust™ Demodex® Wipes™ |
| I-LID N LASH PLUS® Eyelid CleanserI-LID N LASH PLUS® Eyelid Cleanser | Other | I-LID N LASH PLUS® Eyelid Cleanser |
| Blephadex Lid WipesBlephadex Lid Wipes | Other | Blephadex Lid Wipes |
| Eye Cleanse Lid WipesEye Cleanse Lid Wipes | Other | Eye Cleanse Lid Wipes |
| BlephademodexBlephademodex | Other | Blephademodex |
Primary outcome
Participant's Subjective discomfort - Baseline
Time frame: Baseline
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 0 seconds after application
Time frame: Immediately after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 15 seconds after application
Time frame: 15 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 30 seconds after application
Time frame: 30 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 45 seconds after application
Time frame: 45 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 60 seconds after application
Time frame: 60 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 75 seconds after application
Time frame: 75 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 90 seconds after application
Time frame: 90 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 105 seconds after application
Time frame: 105 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 120 seconds after application
Time frame: 120 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 135 seconds after application
Time frame: 135 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 150 seconds after application
Time frame: 150 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 165 seconds after application
Time frame: 165 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 180 seconds after application
Time frame: 180 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 195 seconds after application
Time frame: 195 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 210 seconds after application
Time frame: 210 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 225 seconds after application
Time frame: 225 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 240 seconds after application
Time frame: 240 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 255 seconds after application
Time frame: 255 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 270 seconds after application
Time frame: 270 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 285 seconds after application
Time frame: 285 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 300 seconds after application
Time frame: 300 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 330 seconds after application
Time frame: 330 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 360 seconds after application
Time frame: 360 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 390 seconds after application
Time frame: 390 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 420 seconds after application
Time frame: 420 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 450 seconds after application
Time frame: 450 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 480 seconds after application
Time frame: 480 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 510 seconds after application
Time frame: 510 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 540 seconds after application
Time frame: 540 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 570 seconds after application
Time frame: 570 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Participant's Subjective discomfort - 600 seconds after application
Time frame: 600 seconds after application
Rate the intensity of participant's ocular discomfort (0 is no discomfort, 10 is maximal discomfort)
Time to comfortably open the eyes after the application of eyelid cleansing wipe
Time frame: Between 0 and 600 seconds after application
Time to comfortably open the eyes after the application of eyelid cleansing wipe in seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensitive Eyes® Plus Saline Solution, Oust™ Demodex® Wipes™ and I-LID N LASH PLUS® Eyelid Cleanser in people with Dry Eye, run by University of Waterloo at 1 site in Canada.
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 7 inclusion and 9 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 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant's Subjective discomfort - Baseline (time frame: Baseline). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2019.