Trial Outcomes & Findings for Performance and Safety of Otinova® Ear Spray (NCT NCT05370209)

Results Overview

Proportion of subjects who have all signs of swelling, erythema and otorrhea scored as 0 on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) on Day 7

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Day 7

Results posted on

2024-11-15

Participant Flow

Participant milestones

Participant milestones
Measure	Otinova® Ear Spray Otinova® Ear Spray 1-2 sprays, twice daily for 7 days
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Otinova® Ear Spray n=28 Participants Otinova® Ear Spray 1-2 sprays, twice daily for 7 days
Age, Customized 5-17	2 Participants n=28 Participants
Age, Customized >18	26 Participants n=28 Participants
Sex: Female, Male Female	20 Participants n=28 Participants
Sex: Female, Male Male	8 Participants n=28 Participants
Region of Enrollment Sweden	28 participants n=28 Participants

PRIMARY outcome

Timeframe: Day 7

Proportion of subjects who have all signs of swelling, erythema and otorrhea scored as 0 on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) on Day 7

Outcome measures

Outcome measures
Measure	Otinova® Ear Spray n=28 Participants Otinova® Ear Spray 1-2 sprays, twice daily for 7 days Otinova® Ear Spray: Ear spray
Clinical Cure of Clinical Signs Swelling, Erythema and Otorrhea	28 Participants

SECONDARY outcome

Timeframe: Change from Baseline (Day 1) to Day 7

Change in clinical symptoms itching, otalgia and tenderness, from Day 1 to Day 7, based on subject reported outcomes, using a score from 0 to 4, where 0 = no symptoms, 1= Mild, 2 = Moderate, 3= Severe and 4 = Very Severe

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from Baseline (Day 1) to Day 7

Change of pathologic microbes in the ear canal from baseline (Day 1) to Day 7.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from Baseline (Day 1) to Day 7

Proportion of subjects who have signs of otorrhea (moisture) at baseline (Day 1)on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) and show an improvement of 1 or more points at Day 7.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from Baseline (Day 1) to Day 7

Proportion of subjects who have signs of swelling at baseline (Day 1) on a scale from 0-2 (0=none, 1=mild/moderate, 2=severe) and show an improvement of 1 or more points at Day 7.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 7

Questionnaire regarding User handling - "How did you experience the use of the earspray?" and "Was it easy to apply the spray correctly in the ear?" using a 5-point scale: 1=very easy to use, 2=easy to use, 3=neither easy nor difficult to use, 4=difficult to use, 5=very difficult to use

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from Baseline (Day 1) to Day 7

Proportion of subjects with less sleep disruption Day 7 compared to baseline (Day 1), as reported in subject diary

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from Baseline (Day 1) to Day 7

Proportion of subjects with less use of pain relief medication for ear pain on Day 7 compared to baseline (Day 1), as reported in subject diary

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 7

Use of antibiotics for OE symptoms at Day 7

Outcome measures

Outcome data not reported

Adverse Events

Otinova® Ear Spray

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Otinova® Ear Spray n=28 participants at risk Otinova® Ear Spray 1-2 sprays, twice daily for 7 days
Ear and labyrinth disorders Pain in ear	7.1% 2/28 • Number of events 2 • 1 year, 7 months
Musculoskeletal and connective tissue disorders Pain in arm	3.6% 1/28 • Number of events 1 • 1 year, 7 months
Gastrointestinal disorders Stomach flu	3.6% 1/28 • Number of events 1 • 1 year, 7 months
Skin and subcutaneous tissue disorders Skin Ulceration	3.6% 1/28 • Number of events 1 • 1 year, 7 months

Additional Information

Maria Carlsson

Circius Pharma AB

Phone: +46 (0) 31-81 84 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place