A Study of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage
Study Details
Study Description
Brief Summary
The purpose of this study is to proactively collect customer feedback on the performance aspects and risk factors of Olynth Nasal Saline Drops/Spray and Olynth Ectomed Nasal Spray.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Olynth Nasal Saline Drops/Spray and Olynth Ectomed Nasal Spray Participants who have personally used or administered the Olynth Nasal Saline Drops/Spray and Olynth Ectomed Nasal Spray to a child at least once within the past 6 months will provide feedback via electronic survey on the prior use of the Drop/Spray. |
Outcome Measures
Primary Outcome Measures
- Participant Feedback on the Performance Aspects of Olynth Nasal Saline Drops [Up to 1 month and 14 days]
Participant feedback on the performance aspects of Olynth Nasal Saline Drops will be assessed via electronic survey.
- Participant Feedback on the Performance Aspects of Olynth Nasal Saline Spray [Up to 1 month and 14 days]
Participant feedback on the performance aspects of Olynth Nasal Saline Spray will be assessed via electronic survey.
- Participant Feedback on the Performance Aspects of Olynth Ectomed Nasal Spray [Up to 1 month and 14 days]
Participant feedback on the performance aspects of Olynth Ectomed Nasal Spray will be assessed via electronic survey.
- Number of Participants with Adverse Events (AEs) [Up to 1 month and 14 days]
An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in participants, users or other persons, whether or not related to the investigational device.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 18 years or older who has personally used or administered the nasal drops/spray to a child
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Has personally used or administered to a child, the Nasal Drops/Spray at least once within the past 6 months
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Able to read, write, speak, and understand German
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Has internet access to complete an on-line survey
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Intends to complete the survey
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Individual has signed the informed consent document (ICD)
Exclusion Criteria:
- Is an employee/contractor or immediate family member of the principal investigator (PI), Schlesinger group, product perceptions limited (PPL) Insights or sponsor of this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Schlesinger Group | Berlin | Germany | D-10789 |
Sponsors and Collaborators
- Johnson & Johnson Consumer Inc. (J&JCI)
Investigators
- Principal Investigator: Akash Pandhare, MD. Ph.D., Johnson & Johnson Consumer Inc. (J&JCI)
Study Documents (Full-Text)
None provided.More Information
Publications
- Chirico G, Quartarone G, Mallefet P. Nasal congestion in infants and children: a literature review on efficacy and safety of non-pharmacological treatments. Minerva Pediatr. 2014 Dec;66(6):549-57. Review.
- Eichel A, Wittig J, Shah-Hosseini K, Mösges R. A prospective, controlled study of SNS01 (ectoine nasal spray) compared to BNO-101 (phytotherapeutic dragées) in patients with acute rhinosinusitis. Curr Med Res Opin. 2013 Jul;29(7):739-46. doi: 10.1185/03007995.2013.800474. Epub 2013 May 14.
- Köksal T, Çizmeci MN, Bozkaya D, Kanburoğlu MK, Şahin Ş, Taş T, Yüksel ÇN, Tatli MM. Comparison between the use of saline and seawater for nasal obstruction in children under 2 years of age with acute upper respiratory infection. Turk J Med Sci. 2016 Jun 23;46(4):1004-13. doi: 10.3906/sag-1507-18.
- Spector SL, Toshener D, Gay I, Rosenman E. Beneficial effects of propylene and polyethylene glycol and saline in the treatment of perennial rhinitis. Clin Allergy. 1982 Mar;12(2):187-96.
- CCSURA003229
- CCSURA003229