Trial Outcomes & Findings for Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes (NCT NCT01908803)

Results Overview

A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

Day 3 post-treatment up to Day 8 or Early Exit

Results posted on

2017-12-06

Participant Flow

Subjects were recruited from 12 study centers located in the US.

Of the 84 enrolled, 14 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (70).

Participant milestones

Participant milestones
Measure	AL-60371/AL-817 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)	CIPRODEX Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
Overall Study STARTED	46	24
Overall Study Treated	44	24
Overall Study COMPLETED	42	23
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AL-60371/AL-817 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)	CIPRODEX Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
Overall Study Adverse Event	1	0
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	1	0
Overall Study Randomization Error	1	0
Overall Study Adverse Event (pre-treatment)	1	0

Baseline Characteristics

Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AL-60371/AL-817 n=44 Participants 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)	CIPRODEX n=24 Participants Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days	Total n=68 Participants Total of all reporting groups
Age, Continuous	2.9 years STANDARD_DEVIATION 2.60 • n=5 Participants	2.4 years STANDARD_DEVIATION 1.54 • n=7 Participants	2.7 years STANDARD_DEVIATION 2.28 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	9 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	15 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 3 post-treatment up to Day 8 or Early Exit

Population: This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.

A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.

Outcome measures

Outcome measures
Measure	AL-60371/AL-817 n=39 Participants 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)	CIPRODEX n=22 Participants Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit	38.5 percentage of subjects	31.8 percentage of subjects

SECONDARY outcome

Timeframe: Day 8

Population: This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.

Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success.

Outcome measures

Outcome measures
Measure	AL-60371/AL-817 n=39 Participants 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)	CIPRODEX n=22 Participants Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
Proportion of Subjects With Microbiological Success at the Day 8 Visit	NA percentage of subjects Standard Deviation NA This outcome measure was not analyzed as a consequence of the study's early termination.	NA percentage of subjects Standard Deviation NA This outcome measure was not analyzed as a consequence of the study's early termination.

SECONDARY outcome

Timeframe: Time to event, up to Day 8

Population: This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.

Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries.

Outcome measures

Outcome measures
Measure	AL-60371/AL-817 n=39 Participants 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)	CIPRODEX n=22 Participants Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
Median Time (in Days) to Cessation of Otorrhea	NA days Standard Error NA This outcome measure was not analyzed as a consequence of the study's early termination.	NA days Standard Error NA This outcome measure was not analyzed as a consequence of the study's early termination.

Adverse Events

Pre-treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AL-60371/AL-817

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

CIPRODEX

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pre-treatment n=84 participants at risk Includes all subjects prior to administration of study medication	AL-60371/AL-817 n=44 participants at risk Includes all subjects administered a dose of AL-60371/AL-817	CIPRODEX n=24 participants at risk Includes all subjects administered a dose of CIPRODEX®
Infections and infestations Otitis media acute	0.00% 0/84 • Adverse events (AEs) were collected for the duration of subject participation in the study (8-10 days). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	6.8% 3/44 • Adverse events (AEs) were collected for the duration of subject participation in the study (8-10 days). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	4.2% 1/24 • Adverse events (AEs) were collected for the duration of subject participation in the study (8-10 days). AEs are reported as pre-treatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.

Additional Information

Sr Clinical Project Lead, GCRA, Pharma

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER