A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% Otic Solution Compared to Ciprofloxacin 0.3% Otic solution and to Fluocinolone Acetonide 0.025% Otic Solution in the Treatment of Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric Patients.CIFLOTIII/10IA02

Study ID
STU 112012-042

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Angelia Riley
214-456-8588
angelia.riley@childrens.com

Principal Investigator
Ron Mitchell

Summary

This is a multicenter, randomized, double-blinded study to assess the efficacy and safety
of Ciprofloxacin 0.3% plus Fluocinolone acetonide 0.025% otic solution compared to
Ciprofloxacin 0.3% otic solution and to Fluocinolone acetonide 0.025% otic solution in
the treatment of acute otitis media with tympanostomy tubes in pediatric patients.
Patients selected for the study will be male or female, from 6 months to 12 years old (less
than 13 years old), with uncomplicated acute otitis media with tympanostomy tubes in at
least one ear.

The objectives of the present study are to evaluate the efficacy and safety of topical
Ciprofloxacin 0.3% plus Fluocinolone acetonide 0.025% otic solution compared to
Ciprofloxacin 0.3% otic solution and to Fluocinolone acetonide 0.025% otic solution,
when administering one vial twice daily during 7 days.

The primary endpoint is to demonstrate therapeutic superiority of Ciprofloxacin plus
Fluocinolone acetonide relative to both Ciprofloxacin and Fluocinolone acetonide for
time to cessation of otorrhea in pediatric patients suffering from aoMT

Participant Eligibility

1. Patient of either sex between 6 months and 12 years of age (both inclusive)
2. Patients with patent tympanostomy tube in the ear which will be treated (must be
present and open)
3. Patients suffering from otorrhea for 3 weeks or less
4. Moderate or severe purulent otorrhea at inclusion
5. Signed informed consent from the patient[Single Quote]s legally authorized representative; also, if
the patient is capable of providing assent, signed assent from the patient.