An interventional study of Acetic Acid 2% Ear Drops and Ciprofloxacin 0.3% Otic Solution in Otitis Media Chronic, sponsored by Dow University of Health Sciences. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Dow University of Health Sciences · Not applicable, Interventional, and Treatment
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.
Background and rationale:
Chronic Suppurative Otitis Media (CSOM) is a chronic inflammatory condition of the middle ear and mastoid cavity characterized by persistent or recurrent ear discharge through a perforated tympanic membrane. It is more common in developing countries and can lead to complications including tympanosclerosis, cholesteatoma, and ossicular necrosis if inadequately treated.
Current treatment:
Tubotympanic CSOM is primarily managed conservatively with aural toilet and topical antimicrobial therapy. Topical ciprofloxacin is commonly used because of its effectiveness against CSOM pathogens and favorable safety profile. However, increasing antibiotic resistance has encouraged the evaluation of alternative topical treatment options.
Rationale for acetic acid:
Previous studies have reported beneficial outcomes with topical acetic acid in patients with CSOM. Acetic acid has also been reported as a potentially cost-effective and readily available alternative treatment. The present study will evaluate whether 2% acetic acid ear drops are effective in achieving a dry ear compared with conventional topical ciprofloxacin therapy.
Study objective:
The objective of this study is to compare the effectiveness of 2% acetic acid ear drops versus 0.3% ciprofloxacin ear drops in the medical management of chronic suppurative otitis media. Effectiveness will primarily be assessed by achievement of a dry ear after one month of treatment, defined as absence of moisture or discharge on clinical examination with an otological symptom score of ≤2.
Study design and setting:
This is a parallel-group randomized controlled trial with 1:1 allocation. The study will be conducted in the Department of Otorhinolaryngology, Dr. Ruth K.M. Pfau Civil Hospital, Karachi. The study will be conducted over a period of six months following approval from the College of Physicians and Surgeons Pakistan (CPSP) and the Institutional Review Board (IRB) of Dow University of Health Sciences.
Study population:
The study will include 146 participants aged 18-70 years with tubotympanic-type CSOM who fulfil the predefined inclusion and exclusion criteria. The calculated sample size was 124 participants (62 per group), with an additional 15% allowance for anticipated dropouts and loss to follow-up, resulting in a final recruitment target of 146 participants (73 per group).
Randomization and allocation:
Eligible participants who provide written informed consent will be randomly allocated to one of two treatment groups using a computer-generated randomization sequence. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes, which will be opened after baseline assessment. The study will use a single-blinded design in which the outcome assessor will remain unaware of the treatment allocation.
Intervention group:
Participants allocated to the acetic acid group will receive 2% acetic acid ear drops, with 3 drops administered into the affected ear three times daily for one month.
Comparator group:
Participants allocated to the comparator group will receive 0.3% ciprofloxacin otic drops, with 3 drops administered into the affected ear three times daily for one month.
Follow-up and assessment:
Participants will undergo clinical assessment at baseline and follow-up visits on the 7th, 14th, and 30th days. Otoscopic examination and otological symptom scoring will be performed to assess treatment response. Treatment compliance will be assessed through medication review, treatment diaries, and participant reporting.
Primary outcome:
The primary outcome is achievement of a dry ear after one month of treatment, defined as absence of moisture or discharge on clinical examination with an otological symptom score of ≤2.
Secondary outcomes:
Secondary outcomes include reduction in ear discharge, improvement in otological symptoms such as otorrhea, ear discomfort and itching, treatment compliance and tolerability, recurrence or persistence of ear discharge, and adverse effects associated with treatment.
Data analysis:
Data will be entered and analyzed using SPSS version 26. Descriptive statistics will be reported with 95% confidence intervals. Continuous variables will be assessed for normality using the Shapiro-Wilk test. The Chi-square test will be used to compare treatment efficacy between the two groups, while Fisher's exact test will be used where appropriate. A p-value ≤0.05 will be considered statistically significant.
Expected contribution:
The study aims to determine whether 2% acetic acid ear drops can provide an effective, safe, and potentially cost-efficient alternative to conventional topical ciprofloxacin therapy in the medical management of CSOM. The findings may contribute to evidence-based treatment of CSOM and help identify an accessible treatment option for patients.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's planned enrollment of 146 is below the median of 165 across 174 interventional studies indexed under Otitis Media.
Browse Otitis Media studies →Dow University of Health Sciences is the lead sponsor of 179 studies on the registry; 34 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 30 days after intial treatment
Ear discharge status
Presence and severity of ear discharge assessed clinically at each follow-up visit
Time frame: 7, 14 and 30 days after the initiation of treatment
Otological symptom score
Otological symptoms of patient like reduction of discharge , ear itching and other study specified symptoms assessed using the predefined otological symptom score.
Time frame: 7, 14 and 30 days after the initiation of treatment
Treatment adherence and tolerability
Treatment adherence assessed by partcipant-reported use of the study medication , and tolerability assessed by recording adverse symptoms or local reactions asssociated with the treatment.
Time frame: 30 days after initiation of treatment.
ear discharge status at followup.
Presence or absence of ear discharge on clinical examination following completion of treatment period.
Time frame: 30 days after completion of treatment
5. Adverse effects associated with treatment
To assess the adverse effects associated with treatment
Time frame: 30 days after initiation of treatment
Plan to share: No — 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.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Nov 2026, 1 month later.
Of 36 non-industry interventional studies with no phase under Otitis Media, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 64. This study's planned 1 month is below that.
Counting every sponsor, half of 45 studies reached it within 38 months; a quarter within 13 and three quarters within 51.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetic Acid
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