Clinical trial: A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP) (NCT04305184)

Eligibility criteria:
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 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.

        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.

               -  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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction