Astellas Pharmaceuticals: Chronic Tympanic Membrane Perforation
A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)
The primary purpose of this study is to evaluate the safety and tolerability of ASP0598 Otic Solution. This study will also evaluate the efficacy of ASP0598 Otic solution.
- Subject has dry chronic tympanic membrane perforation (CTMP) documented as persisting longer than 3 months.
- A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- WOCBP who agrees to follow the contraceptive guidance starting at screening and for at least 28 days after investigational product (IP) application on Day 1.
- Female subject must agree not to breastfeed starting at drug application on Day 1 and for at least 28 days after IP application.
- Female subject must not donate ova starting on Day 1 and for at least 28 days after investigational product (IP) application.
- A male subject with female partner(s) of child-bearing potential must agree to use contraception starting on Day 1 and for at least 28 days after IP application.
- A male subject must not donate sperm starting on Day 1 and for at least 28 days after IP application.
- Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom from Day 1 and for at least 28 days after IP application.
- Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
- Subject agrees not to participate in another interventional study while receiving IP.
- Subject has one of following conditions that may affect the ipsilateral side of the ear with chronic tympanic membrane perforation (CTMP):
- Perforation involving 3 or more quadrants.
- Pin hole perforation (only for the expansion cohort).
- Presence of tympanosclerosis adjacent to the perforation.
- Perforation involves malleus erosion.
- Absent malleus.
- Marginal perforation (i.e., involving the annulus or exposing the handle of malleus).
- Tympanic membrane perforation (TMP) caused by electric/slag/blast/burn injury.
- Post radiated TMP.
- History of tympanic membrane repair by any type of live tissue.
- History of otorrhea or active treatment for otorrhea within the last 3 months prior to Screening.
- Bellucci otorrhea grade 3 or above.
- Active external ear canal inflammation (otitis externa, dermatitis) or within the last 3 months prior to Screening.
- Active diagnosis of Eustachian Tube dysfunction or diagnosis within 6 months prior to Screening.
- Craniofacial abnormalities, History of head and neck surgery within the last 3 months prior to Screening, history of radiation to head and neck.
- Recent (within 2 weeks) diagnosis of upper respiratory tract infection.
- Presence or history of cholesteatoma.
- Presence of pars-flaccida or pars tensa retraction or adhesion.
- Presence or history of tumors of the middle or external ear.
- Contraindications to tympanic membrane closure.
- An audiometric finding indicates a characteristic of Carhart’s notch which is an increase in bone conduction threshold with a peak at 2,000 Hz.
- Only hearing or better hearing ear.
- Whole circumference of the tympanic membrane perforation is not visible by endoscope.
- Presence/history of eosinophilic otitis media in either ear.
- Subject has a presence of adhesive otitis media in the contralateral ear.
- Subject has a presence of any wound healing systemic condition.
- Subject has Obstructive Sleep Apnea where the subject is required to use Continuous Positive Airway Pressure (CPAP) during the study period.
- Subject is exposed in their daily life to high volume of water into the ear canal (e.g., swimmer or surfer).
- Subject has health conditions that would prevent him/her from fulfilling the study requirements on the basis of medical history and laboratory test (Serum Chemistries, complete blood count [CBC] with Differential, Urinalysis) results at the screening visit.
- Subject is receiving any other investigational agents during study participation.
- Subject has any form of substance abuse, or psychiatric illness/social situations that would limit compliance with study requirements, or a condition that could invalidate communication.
- Subject has a known or suspected hypersensitivity to ASP0598, or any components of the formulation used.
- Subject has had previous exposure with ASP0598.
- Subject is unlikely to comply with the visits scheduled in the protocol.
For more information please call 502.893.0159 and ask for Research