Clinical trial: FX-322 in Sensorineural Hearing Loss (NCT03616223)

Eligibility criteria:
Inclusion Criteria:

          1. Adult aged 18-65 years.

          2. Established diagnosis of stable sensorineural hearing loss (no changes of 10 dB or
             more at any frequency) by standard audiometric measures for >6 months.

          3. Documented medical history consistent with hearing loss being caused by noise exposure
             or sudden sensorineural hearing loss (documented audiogram at least 6 months prior to
             screening required).

          4. Female subjects must be of non-childbearing potential or will need to utilize two
             methods of highly effective contraception during the study participation (e.g.
             hormonal contraception or an intrauterine device and condoms) or remain abstinent.
             Male subjects should use condoms with spermicide during the course of the study or
             remain abstinent. Subjects should not donate sperm or ova during the study period.

        Exclusion Criteria:

          1. Perforation of tympanic membrane or other tympanic membrane disorders that would
             interfere with the delivery and safety assessment of an intratympanic medication or
             reasonably be suspected to affect tympanic membrane healing after injection in either
             ear. This includes a current tympanostomy tubes.

          2. Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear.

          3. A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the
             ear to be injected.

          4. Active chronic middle ear disease or a history of major middle ear surgery, as an
             adult, in the ear to be injected.

          5. Subject has had an intratympanic injection in either ear within 6 months of the
             screening visit.

          6. History of clinically significant vestibular symptoms at the discretion of the
             investigator.

          7. History of clinically significant systemic autoimmune disease (e.g. rheumatoid
             arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).

          8. History of head or neck radiation treatment or exposure.

          9. History of substance abuse within 2 years of the Screening Visit.

         10. Positive urine pregnancy test or breast-feeding.

         11. Any known factor, condition or disease that, in the view of the investigator, might
             interfere with treatment compliance, study conduct or interpretation of the results
             such as psychiatric disease or suicidal tendencies.
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