J30.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Presence of a signed and dated informed consent form from the patient -Presence of a suspected diagnosis of allergic rhinoconjunctivitis -Patient is able to fill out the questionnaires -Consent to subcutaneous or sublingual immunotherapy
Exclusion criteria
Exclusion criteria: -Current participation in other clinical trials -Acute or chronic eye diseases especially all forms of conjunctivitis or glaucoma -Severe acute and/or chronic organic or mental illness, including the presence of epilepsy -Contraindications to SLIT/SCIT -Inadequate method of contraception (double contraception is necessary) -Pregnancy -Chronic non-allergic rhinitis -Intolerance to antihistamines and/or cortisone preparations -Presence of type III and/or type IV allergy -Current or expired complementary medical therapy as well as planned complementary medical therapy during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proof of the usability and effectiveness of the “AllergoEye” system in diagnostics and during the three-year therapy in 50 patients with allergic rhinoconjunctivitis | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Confirmation that when comparing the results of the “AllergoEye” with the subjective assessment of the medical staff, “AllergoEye” demonstrates a better qualitative and quantitative performance. b. Proof that the accuracy of the Summation Symptom Scores is qualitatively increased when using the “AllergoEye” redness measurement instead of the subjective assessment by medical staff. c. Proof that the results obtained by “AllergoEye” correlate exactly with the Summation Symptom Scores and that “AllergoEye” is therefore able to replace the complex, subjective methodology of the Summation Symptom Scores. | — |
Countries
Germany
Contacts
Praxis für HNO und Allergologie Dr. Yury Yarin