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.
- 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