A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)

Inclusion Criteria:

   - Subject has 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.

   - 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
   refraining from using prohibited concomitant medications.

   - Subject agrees not to participate in another interventional study during the study
   period.

Exclusion Criteria:

   - 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.

      - Active 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 hertz (Hz).

      - Only hearing ear or better hearing ear and the contralateral ear ≥ 40 dB
      (decibels) by average four-frequency (500, 1000, 2000 and 4000 Hz).

      - 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.