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NCT05126407 Clinical Trial

A Study of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage

Sinusitis Clinical Trial

Official title:
A Non-Interventional Clinical Study to Assess the Risk and Performance Aspects of Olynth Saline/Ectomed Nasal Drops/Spray Based Upon Previous Usage

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05126407
Other study ID # CCSURA003229
Secondary ID CCSURA003229
Status Completed
Phase
First received
Last updated
Start date December 17, 2021
Est. completion date January 20, 2022

Study information
Verified date January 2023
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 87
Est. completion date January 20, 2022
Est. primary completion date January 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged 18 years or older who has personally used or administered the nasal drops/spray to a child - Has personally used or administered to a child, the Nasal Drops/Spray at least once within the past 6 months - Able to read, write, speak, and understand German - Has internet access to complete an on-line survey - Intends to complete the survey - 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Schlesinger Group Berlin

Sponsors (1)
Lead Sponsor Collaborator
Johnson & Johnson Consumer Inc. (J&JCI)

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

Eichel A, Wittig J, Shah-Hosseini K, Mosges R. A prospective, controlled study of SNS01 (ectoine nasal spray) compared to BNO-101 (phytotherapeutic dragees) 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. — View Citation

Koksal T, Cizmeci MN, Bozkaya D, Kanburoglu MK, Sahin S, Tas T, Yuksel CN, 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. — View Citation

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. doi: 10.1111/j.1365-2222.1982.tb01638.x. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Participant Feedback on the Performance Aspects of Olynth Nasal Saline Drops Participant feedback on the performance aspects of Olynth Nasal Saline Drops will be assessed via electronic survey. Up to 1 month and 14 days
Primary Participant Feedback on the Performance Aspects of Olynth Nasal Saline Spray Participant feedback on the performance aspects of Olynth Nasal Saline Spray will be assessed via electronic survey. Up to 1 month and 14 days
Primary Participant Feedback on the Performance Aspects of Olynth Ectomed Nasal Spray Participant feedback on the performance aspects of Olynth Ectomed Nasal Spray will be assessed via electronic survey. Up to 1 month and 14 days
Primary Number of Participants with Adverse Events (AEs) 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. Up to 1 month and 14 days
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