NCT07835425

Brief Summary

This randomized controlled trial aims to compare the effectiveness of 2% acetic acid ear drops with 0.3% ciprofloxacin ear drops in the medical management of chronic suppurative otitis media (CSOM). The study will be conducted among adults aged 18 to 70 years attending the Otorhinolaryngology Department of Dr. Ruth K.M. Pfau Civil Hospital, Karachi. Participants will be randomly allocated to receive either 2% acetic acid or 0.3% ciprofloxacin ear drops three times daily for one month. Treatment effectiveness will be assessed by achievement of a dry ear and improvement in otological symptom score.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Sep 2026Jan 2027

First Submitted

Initial submission to the registry

September 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 23, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2027

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 13, 2026

Last Update Submit

September 20, 2026

Conditions

Otitis Media Chronic

Keywords

CSOM ,ACETIC ACID DROPS

Outcome Measures

Primary Outcomes (1)

  • Dry ear status after 30 days.

    Proportion of participant with a dry ear: defined as absence of moisture or ear discharge on clinical examination with an otological symptom score of ≤2 after 30 days of initial treatment.

    30 days after intial treatment

Secondary Outcomes (5)

  • Ear discharge status

    7, 14 and 30 days after the initiation of treatment

  • Otological symptom score

    7, 14 and 30 days after the initiation of treatment

  • Treatment adherence and tolerability

    30 days after initiation of treatment.

  • ear discharge status at followup.

    30 days after completion of treatment

  • 5. Adverse effects associated with treatment

    30 days after initiation of treatment

Study Arms (2)

2% Acetic Acid Ear Drops

EXPERIMENTAL

Participants will receive 2% acetic acid ear drops, 3 drops in the affected ear three times daily for one month.

Drug: Acetic Acid 2% Ear Drops

0.3% Ciprofloxacin Ear Drops

ACTIVE COMPARATOR

Participants will receive 0.3% ciprofloxacin ear drops, 3 drops in the affected ear three times daily for one month.

Drug: Ciprofloxacin 0.3% Otic Solution

Interventions

Acetic Acid 2% Ear DropsDRUG

2% acetic acid ear drops, 3 drops administered into the affected ear three times daily for one month. Participants will self-administer the assigned medication after appropriate instructions.

2% Acetic Acid Ear Drops
Ciprofloxacin 0.3% Otic SolutionDRUG

0.3% ciprofloxacin otic solution, 3 drops administered into the affected ear three times daily for 30 days. Participants will self-administer the medication after appropriate instructions.

0.3% Ciprofloxacin Ear Drops

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • Either sex
  • Persistent, non-foul-smelling ear discharge for ≥3 months
  • Tubotympanic type chronic suppurative otitis media
  • Baseline otological symptom score ≥5

You may not qualify if:

  • Immunocompromised patients
  • External auditory canal pathology
  • Ear malignancy
  • Known hypersensitivity to acetic acid or ciprofloxacin
  • Pregnant women or lactating mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Ruth K. M. Pfau Civil Hospital Karachi

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Interventions

Acetic AcidUreaCiprofloxacin

Intervention Hierarchy (Ancestors)

AcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipidsAmidesFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Asra Waseem, MBBS

CONTACT

+92 330 8174297waseem.asra34@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2026

First Posted

September 22, 2026

Study Start

September 23, 2026

Primary Completion (Estimated)

November 18, 2026

Study Completion (Estimated)

January 18, 2027

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

The primary ownership of the collected data will remain with Dow University of Health Sciences. Individual Participant Data (IPD) will not be shared with any external institution or organization because of confidentiality, privacy, and data protection considerations. Access to the data will be restricted to the authorized study investigators and relevant institutional authorities. Any data used for publication or dissemination will be presented in an anonymized and aggregated form to ensure that individual participants cannot be identified.

Locations

PA(1)