None listed
Conditions
Interventions
Medical Device : Distribute the medical device for clinical trial by randomly assigning the subjects who meet the selection criteria.
The subject that receives the medical device is to insert a laser
Sponsors
Optowell
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with allergic rhinitis (rhinorrhea, sneezing and nasal itching) who were allergic to the allergen within 12 months 2. Patients with total nasal Symptom score (TNSS) of 0 to 9 on the screening visit date 3. Aged = 19 years 4. Those who have no problem in expressing their opinions 5. Voluntary written consent to the subject consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who are expected to be inadmissible for the use of concomitant medication prescribed in the protocol 2. Person who received laser treatment for allergic rhinitis within the last 14 days 3. A person who has a serious disease such as malignant tumor, anemia, active pulmonary tuberculosis, infection or systemic disease 4. A person with anatomical obstruction or deformation in the nasal cavity or surgical history (within the last 6 months) 5. A person with active respiratory disease such as asthma 6. A person with hypertension or diabetes 7. A person who have received immunotherapy or systemic adrenal cortical hormone treatment within the last 6 months 8. A person who is sensitive to laser light or is taking medications 9. A person who have a wound on the irradiated area 10. Women who are pregnant or breast-feeding or are likely to become pregnant 11. A person who have participated in other clinical trials within the past month 12. A person who judged by other investigator to be unable to perform clinical trials properly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change value after 4 weeks compared to baseline of TNSS(Total Nasal Symptom Score) | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference of RQLQ(Questionnaire on the effect of allergic rhinitis on quality of life) score after 4 weeks(Visit 4) of treatment compared that of the basse line(Visit 2)- Activity due to nasal and eye symptomes/ sleeping conditions due to nasal and eye symptoms/ Symptoms other than nose and eye (fatigue, thirst, concentration, headache)/Difficulty due to nasal and eye symptoms/Discomfort due to nasal symptoms/Discomfort due to eye symptoms/ Discomfort of feeling due to nasal and eye symptoms | — |
Countries
Korea, Republic of
Contacts
Public ContactMi Lee
Dankook Univeristy Hospital
Outcome results
None listed