VetMed

Otitis externa in dogs: single-application long-acting otic treatment vs daily topical drops — POSSIBLE (the treatment made no difference to clinical cure)

In dogs with otitis externa, does a single-application long-acting otic gel vs daily topical drops give equal cure with better compliance?

Shelf #491 · gate-verified and displayed under the developer's blinded-trial rule

POSSIBLE (the treatment made no difference to clinical cure): The null suffix is scoped to cure — on clinical success, clinic-applied long-acting products match repeated-application products in every carded randomised trial, while the compliance-side advantage is structural and quality-of-life based rather than a measured adherence rate. In Noli 2017, the one direct test against daily drops (50 client-owned dogs with acute otitis externa, randomly allocated), a veterinarian-administered terbinafine–florfenicol–betamethasone gel applied twice, one week apart, and owner-administered daily otic drops for 2 weeks improved all parameters significantly in both groups, with no difference in improvement of the OTI-3 otitis score between groups at any time point; quality-of-life scores for dogs and owners improved significantly more in the gel group at all time points except owner quality of life on day 28 (P < 0.05), and cytology and pruritus improved significantly more by day 7 in the gel group (P = 0.0026 and P = 0.0294). In Heuer 2024 (316 dogs, examiner-masked randomised field trial), a single in-clinic dose of gentamicin–posaconazole–mometasone suspension was significantly non-inferior to a twice-applied florfenicol–terbinafine–betamethasone control gel: day-28 treatment success 89.5% (128/143) versus 87.2% (116/133). In Blake 2017 (221 dogs, masked randomised field study), a single-administration florfenicol–terbinafine–mometasone solution achieved a 72.5% treatment success rate versus 11.1% for its control in cases caused by Staphylococcus pseudintermedius and Malassezia pachydermatis (P = 0.0001), establishing that one application is genuinely effective treatment, not merely convenient. Design class (a): randomisation and blinding are both established by carded records (Heuer 2024 'examiner-masked, randomised'; Blake 2017 'masked and randomised'). The honest limits: the daily-drops comparison rests on one 50-dog trial whose record states no blinding, no carded trial counted missed doses or measured owner compliance directly, and each trial tests a different product pair — so 'equal cure' is a pattern across products, and the compliance claim is that clinic application removes home dosing (with better quality-of-life scores in Noli), not a proven adherence percentage. The claim-carrying records of Shelf #142 (Rigaut 2024, King 2018, Forster 2018) were desk-checked and are NOT re-carded here. Drafted Nov 10, 2026 (VetMed build, topic #491); all figures from abstracts fetched and verified at drafting.

Noli 2017: a vet-applied otic gel (two applications, one week apart) matched owner-applied daily drops on the otitis score in 50 dogs with acute otitis externa — and beat them on quality of life, cytology and pruritus at day 7

Randomised controlled trial (record's own wording: 'Fifty client-owned dogs randomly randomized into two groups'; publication types include Randomized Controlled Trial and Multicenter Study; blinding not stated in the record)

Who: Dogs: 50 client-owned dogs with acute otitis externa, randomly allocated to two groups and treated for 2 weeks. Group A: a veterinary licensed otic gel containing terbinafine, florfenicol and betamethasone acetate, administered by veterinarians on two occasions at a 1-week interval. Group B: a veterinary licensed otic drop-based product administered by owners once daily, along with twice-weekly ear cleaning. Veterinarians evaluated otitis with the OTI-3 scale and semi-quantitative cytology on days 0, 7, 14 and 28; owners assessed quality of life (validated questionnaire) and pruritus (visual analogue scale) at each visit.

Result: In both groups, all parameters improved significantly. There was no difference in improvement of OTI-3 between groups at any time point. There was a significantly higher improvement of quality-of-life scores, for dogs and owners, in Group A compared to Group B at all time points (P < 0.05), except for owner quality of life on Day 28. Group A cytology scores and pruritus improved significantly more by Day 7 (P = 0.0026 and P = 0.0294 respectively). The authors conclude a veterinarian-administered otic gel provided equivalent efficacy and higher quality of life to dogs with otitis externa and their owners, compared to an owner-administered topical otic therapy.

Watch out: This is the shelf's only direct daily-drops comparison and it is small (50 dogs); its record states no blinding, the two arms also differed in who applied treatment and in ear cleaning (twice-weekly cleaning in the drops group only), and the abstract reports no numeric quality-of-life or otitis scores — only the significance statements carded here. 'Equivalent efficacy' is the authors' conclusion from no significant difference, not a pre-specified non-inferiority test as in Heuer 2024. Distinct from King 2018 and Forster 2018 on Shelf #142, which test the same gel against other comparators and are not re-carded here.

Noli C, Sartori R, Cena T. Impact of a terbinafine-florfenicol-betamethasone acetate otic gel on the quality of life of dogs with acute otitis externa and their owners. Vet Dermatol. 2017;28(4):386-e90. PMID: 28295766. Registry ID: none in the record. MeSH: Acute Disease · Administration, Topical · Animals · Anti-Infective Agents/administration & dosage, therapeutic use* · Anti-Inflammatory Agents/administration & dosage, therapeutic use* · Betamethasone/administration & dosage, therapeutic use* · Dog Diseases/drug therapy* · Dogs · Drug Combinations · Female · Gels · Humans · Male · Naphthalenes/administration & dosage, therapeutic use* · Otitis Externa/drug therapy, veterinary* · Quality of Life · Terbinafine · Thiamphenicol/administration & dosage, analogs & derivatives*, therapeutic use

Heuer 2024: a single in-clinic dose of gentamicin–posaconazole–mometasone was non-inferior to a twice-applied florfenicol–terbinafine–betamethasone gel — day-28 success 89.5% vs 87.2% in 316 dogs

Multicentre, controlled, examiner-masked, randomised field trial (record's own wording; publication types include Randomized Controlled Trial, Veterinary and Multicenter Study)

Who: Dogs: 316 dogs with otitis externa in a multicentre field trial over 42 days, treated once on day 0 with the investigational single-dose otic suspension containing gentamicin, posaconazole and mometasone furoate, administered in-clinic by a veterinary professional, or twice (days 0 and 7) with a control product containing florfenicol, terbinafine and betamethasone acetate. The primary endpoint was a composite otitis index score of 4 or less (of 12) on day 14 and 3 or less (of 12) on day 28. Day-28 success denominators were 143 (single-dose) and 133 (control) dogs.

Result: On day 28, treatment success was recorded in 128 of 143 single-dose-treated dogs (89.5%), significantly non-inferior to 116 of 133 (87.2%) control-treated dogs (Farrington-Manning test, Z = 4.1351, p < 0.0001) — an absolute difference of 2.3 percentage points. For mixed cultures of Staphylococcus pseudintermedius and Malassezia pachydermatis, treatment success was 100% in single-dose dogs (n = 33), significantly non-inferior to 90.2% (37 of 41) in control dogs (Z = 3.1954, p = 0.0007). The authors state the single-dose product was developed to improve compliance and offers enhanced compliance and welfare by eliminating the owner burden of treating this painful condition.

Watch out: The comparator is a twice-applied gel, not daily drops — this card establishes that one clinic application matches a two-application long-acting product, and the daily-drops link in the shelf's chain comes from Noli 2017. Efficacy in chronic otitis externa was not investigated, and cytology was not used to aid diagnosis or identify secondary pathogens. Denominators at day 28 (143 and 133) are smaller than the 316 dogs enrolled, as reported in the record.

Heuer L, Wilhelm C, Roy O, Löhlein W, Wolf O, Zschiesche E. Clinical safety and efficacy of a single-dose gentamicin, posaconazole and mometasone furoate otic suspension for treatment of canine otitis externa. Vet Rec. 2024;194(9):e3955. PMID: 38462781. Registry ID: none in the record. MeSH: Animals · Dogs · Dog Diseases*/drug therapy · Otitis Externa*/veterinary, drug therapy, microbiology · Mometasone Furoate*/therapeutic use, administration & dosage · Treatment Outcome · Female · Male · Triazoles*/therapeutic use, administration & dosage · Gentamicins*/therapeutic use, administration & dosage · Anti-Bacterial Agents/therapeutic use, administration & dosage · Drug Therapy, Combination/veterinary · Antifungal Agents/therapeutic use, administration & dosage · Suspensions

Blake 2017: a single administration of florfenicol–terbinafine–mometasone otic solution gave 72.5% treatment success versus 11.1% for control in target-pathogen otitis externa cases (221 dogs enrolled)

Multicentre, controlled, masked and randomised field study (record's own wording: 'a multicentre, controlled, masked and randomised field study')

Who: Dogs: 221 client-owned dogs of varying breeds with diagnosed bacterial and/or fungal otitis externa, enrolled in a multicentre field study over 30 days and randomised to the single-administration otic solution (florfenicol, terbinafine and mometasone furoate) or control groups. The primary effectiveness endpoint was improvement in a clinical severity score at the final visit (day 30); safety analyses were based on clinical and laboratory parameters and adverse events.

Result: The otic solution group demonstrated a significantly higher treatment success rate compared with the control group (72.5 per cent v 11.1 per cent, P value = 0.0001) for cases of otitis externa caused by Staphylococcus pseudintermedius and Malassezia pachydermatis. No significant safety findings were reported. The authors note the single-administration regimen eliminates opportunities for client dosage administration errors and medication stockpiling.

Watch out: The 72.5% versus 11.1% figures apply to the target-pathogen case subset as reported in the abstract, not to all 221 enrolled dogs, and the abstract does not identify what the control treatment was — it is carded as 'control' in the record's own word and must not be read as either placebo or daily drops. This record carries no MeSH terms in PubMed (see source line). Its role on this shelf is to show a single application is genuinely effective treatment against a control, complementing the active-comparator trials.

Blake J, Keil D, Kwochka K, Palma K, Schofield J. Evaluation of a single-administration ototopical treatment for canine otitis externa: a randomised trial. Vet Rec Open. 2017;4(1):e000219. PMID: 29177053. Registry ID: none in the record. MeSH: none in the record (no MeSH terms are listed for this record)

Synthesis: single-application clinic-applied otic products cure otitis externa as well as repeated-application products in randomised trials (the treatment made no difference to clinical cure), and they remove home dosing — better quality of life in the one trial that measured it

Synthesis

Who: Synthesis of the cards above: Noli 2017 (50 client-owned dogs with acute otitis externa, vet-applied gel twice vs owner-applied daily drops), Heuer 2024 (316 dogs, examiner-masked randomised, single-dose suspension vs twice-applied gel) and Blake 2017 (221 dogs, masked randomised, single-administration solution vs control).

Result: (1) Cure: no difference in OTI-3 improvement between gel and daily drops at any time point (Noli); day-28 success 89.5% for a single dose versus 87.2% for a twice-applied gel, formally non-inferior (Heuer); a single administration beat its control 72.5% versus 11.1% in target-pathogen cases (Blake). (2) Compliance side: quality-of-life scores for dogs and owners improved significantly more with the vet-applied gel than with daily home drops (Noli), and both other trials' designs remove owner application entirely — Heuer by a single in-clinic dose, Blake by a regimen its authors note eliminates client dosage errors. (3) Early response: cytology and pruritus improved significantly more by day 7 in the gel group in Noli.

Watch out: No carded trial measured owner compliance as doses given versus doses prescribed — the compliance advantage is inferred from clinic administration and quality-of-life scores, and should be stated that way. The three trials test three different product pairs, none of them the exact pairs on Shelf #142, whose claim-carrying records (PMIDs 38093088, 30305092, 30170597) were desk-checked and deliberately not re-carded here; read together, the two shelves cover combination-product choice (#142) and application burden (this shelf). Results are for acute/uncomplicated otitis externa — Heuer did not investigate chronic cases, and none of these trials addresses Pseudomonas or rod infections.

Synthesis of Noli C et al. PMID: 28295766; Heuer L et al. PMID: 38462781; Blake J et al. PMID: 29177053. Registry IDs as on the individual cards.

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