Study to evaluate whether a growth factor ear drop helps close residual eardrum perforations after surgery

Otoepix-an ear drop containing recombinant human epidermal growth factor and its outcome on postoperative residual tympanic perforation - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/104347

Enrollment

Registered

2026-02-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H958- Other intraoperative and postprocedural complications and disorders of the ear and mastoid process, not elsewhere classified

Interventions

Intervention1: otoepix(recombinant human epidermal growth factor ear drops): otoepix is a topical otic formulation containing rhEGH designed to enhance epithelial regeneration and promote closure of p

Eligibility

Inclusion criteria

Inclusion criteria: 1) age between 18 to 60 years 2) post-surgical residual tympanic membrane perforation in adult(18+) 3)measurable perforation within a defined size range 4)informed consent and study compliance

Exclusion criteria

Exclusion criteria: 1)active ear infection 2)history of abnormal tissue growth(eg-keloids) 3)allergy to rhEGF or ear drop ingredients

Design outcomes

Primary

Measure	Time frame
effectiveness in closing postresidual tympanic membrane perforationTimepoint: AT 4WEEKS,8 WEEKS,12 WEEKS AND POST TREATMENT FOLLOW-UP AT 6 MONTHS	—

Secondary

Measure	Time frame
nilTimepoint: nil	—

Countries

India

Contacts

Public ContactDRSWEATHAVM

saveetha medical college

v.m.sweatha@gmail.com9962109890

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026