A Phase 4 interventional study of Otiprio and Ciprodex in Otorrhea and Otitis Media With Effusion in Children, sponsored by Boston Medical Center. Withdrawn at 1 site in United States. Open to participants aged 6 Months to 10 Years. Per ClinicalTrials.gov, last updated 2018-09-14.
Sponsored by Boston Medical Center · Phase 4, Interventional, and Treatment
Among 27 studies in Otitis Media with Effusion with a site in United States — 7 open to participants now, 8 under way, none of them phase 3. Otitis Media with Effusion · United States.
Among the 27 studies in Otitis Media with Effusion with a site in United States, this one is the 19th largest by enrollment of the 20 interventional ones that give a count, is the only one that started in 2018, is the only one in phase 4, and was the 18th registered.
88 studies on the registry are indexed under Otitis Media with Effusion; 17 are open to participants now.
Browse Otitis Media with Effusion studies →7 of the 27 studies in Otitis Media with Effusion with a site in United States are open now. Recruiting first, the newest first:
ClinQure, Inc. · Sites in United States
Ages 6 mo+
Stanford University · Sites in United States
Ages 1–17
Smith & Nephew, Inc. · Sites in United States
Ages 6 mo–17 yrs
Medical College of Wisconsin · Sites in United States
Ages 12 mo–6 yrs
Philip Perez · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 8 Otitis Media with Effusion studies recruiting now, 1 sets no upper age limit and 7 stop at 75 or younger; 8 take children under 18; 2 take healthy volunteers.
This study: 6 Months to 10 Years · all sexes · no healthy volunteers.
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27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 7 · Phase 4 1
First in 1997; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 82 across the 20 interventional studies, 194 across the 6 observational. Of the 17 that completed or were terminated, 12 (71%) have results posted.
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13 of 27 have an industry lead sponsor. The 10 most frequent:
Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Boston Medical Center has 1 study filed under Otitis Media with Effusion — fewer than ten, so there is no comparison to draw.
4 of the studies in Otitis Media with Effusion with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05353569Medical College of WisconsinCoherent Optical Detection of Middle Ear Disease | 2027-04 |
| NCT06944795Stanford UniversitySWIR Otoscopy Study | 2027-04-30 |
| NCT07625657ClinQure, Inc.CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes | 2027-06 |
| NCT07777302Philip PerezEarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults | 2027-11-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 27 studies in Otitis Media with Effusion with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement in order to prevent tube otorrhea; however, there is a lack of consensus as to which drops are the most effective, and whether a post-operative regimen should be used. Utilizing drops postoperatively places the onus of administration on parents who may have various difficulties in delivering the drops to their child's ears. Additionally, prescribing drops postoperatively is a health care cost. The purpose of this study is to determine if there is a difference in prevention of tympanostomy tube failure (defined as tube blockage or otorrhea) between Otiprio administered once intraoperatively, Ciprodex otic dropgs administered once intraoperatively, and Ciprodex otic drops administered intraoperatively with a postoperative course.
Tympanostomy tube placement is indicated in children with recurrent acute otitis media or chronic otitis media with effusion. Ear dishcarge, otorrhea, is the most common complication following tympanostomy tube placement and occurs in up to 25% of patients. Otorrhea can lead to tube obstruction, making the tube ineffective in ventilating the middle ear or improving hearing. Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement in order to prevent otorrhea and tube blockage; however, there is lack of consensus as to which drops are the most effective and what dosing regimen should be used.
Options for prevention of otorrhea and tympanostomy tube blockage include intraoperative single-dose application of topical drops or postoperative prolonged application of topical drops. One issue with the prolonged application of drops after surgery is the requirement of parents to administer the drops at home. Thus, the delivery of medication to the middle ear is variable given the difficulty of administering ear drops to a child. Another option exists as a one-time application at the time of surgery, but provides an extended duration of medication in the middle ear. Otiprio is a single-dose suspension of ciprofloxacin and has been FDA approved since February 2015 for use in pediatric patients with otitis media with effusion who require tympanostomy tube placement. Otiprio exists as a liquid at or below room temperature and transitions into a gel after exposure to body temperature in the middle ear. Administrated as an injection into the middle ear at the time of tympanostomy tube placement, Otipiro slowly releases antibiotic treatment over the course of a week, eliminating the need for parents to administer drops.
The study is a prospective, randomized (1:1:1), single-blind, trial of three treatment groups in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement. Approximately 300 subjects will be randomized: 100 randomized to receive Otiprio intraoperatively, 100 randomized to receive Ciprodex intraoperatively, and 100 randomized to receive Ciprodex intraoperatively with five days of Ciprodex drops postoperatively.
All participants will undergo tympanostomy tube placement in the operating room as clinically indicated by an Otolaryngologist. Prior to the surgery, the patient will be randomized to one of the three trial arms. During the operation, the surgeon, who will be blinded until completion of tube placement as to which arm the participant is randomized, will administer Otiprio as a one-time intratympanic injection or Ciprodex, by administering 3-5 drops into each ear canal. For the trial arm that includes a 5 day course of Ciprodex postoperatively, the patient's parents will be instructed on how to administer the drops. As per standard of care, all participants will be assessed at a postoperative visit 2-4 weeks post surgery. A blinded assessor to the randomized study arm will perform otoscopy (ear exam) during that visit to determine if there is presence of otorrhea or tympanostomy tube blockage.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Otiprio will be administered through the tympanic membrane by the otolaryngologist immediately after tympanostomy placement.
Drug: Otiprio
Ciprodex drops will be instilled by the otolaryngologist into the affected ear immediately after tympanostomy surgery.
Drug: Ciprodex
Ciprodex drops will be instilled by the otolaryngologist into the ear immediately after tympanostomy tube surgery. The parent or guardian will administer Ciprodex drops into the ears twice daily for five days after surgery.
Drug: Ciprodex
Otiprio is a single-dose, physician-administered, sustained-exposure otic fluoroquinolone antibacterial for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery. Otoprio (6% ciprofloxacin, 60 mg/mL) will be administered through the tube lumen by the otolaryngologist immediately after tympanostomy surgery.
Also known as: ciprofloxacin otic suspension
Ciprodex is a combined antibiotic and steroid ear drop used to treat otitis media with tympanostomy tubes. Four drops of Ciprodex (0.14mL) instilled by the otolaryngologist into the affected ear immediately after tympanostomy surgery. Each mL of Ciprodex contains ciprofloxacin hydrochloride 0.3 % (equivalent to 3 mg ciprofloxacin base) and dexamethasone 0.1 % equivalent to 1 mg dexamethasone
Also known as: ciprofloxacin and dexamethasone
Post operative otorrhea
Otorrhea is drainage from the ear. Evaluation will be performed by a blind assessor via otoscopy.
Time frame: Post operative visit 2-4 weeks after tube placement
Tympanostomy tube blockage
Tympanostomy tube blockage is when the placed tube becomes clogged or obstructed. Evaluation will be performed by a blind assessor via otoscopy.
Time frame: Post operative visit 2-4 weeks after tube placement
Resolution of effusion post operatively
Effusion is the presence of middle ear fluid. Evaluation will be performed by a blind assessor via otoscopy.
Time frame: Post operative visit 2-4 weeks after tube placement
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2018; primary completion for Jun 2019, 8 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ciprofloxacin