Abstract
PURPOSE: To assess the within-treatment efficacy of hot compresses (HC), HC plus tobramycin (Tobrex) and HC plus tobramycin/dexamethasone (Tobradex) for chalazia treatment. METHODS: Design: Multicentre, randomized clinical trial (ClinicalTrials.gov identifier, NCT01230593). SETTING: Two clinical sites in New York and two clinical sites in Ontario. STUDY POPULATION: A total of 149 patients with one or more chalazia on separate eyelids randomly assigned to receive HC (n = 50), HC plus tobramycin (n = 50) or HC plus tobramycin/dexamethasone (n = 49). INTERVENTION: 4-6 weeks of assigned treatment. Patients were measured for chalazion horizontal width and surveyed for pain and treatment satisfaction levels. MAIN OUTCOME MEASURES: Primary outcome was complete resolution (100% size reduction). Secondary outcomes were size change in millimetres and patient reported pre- and post-treatment pain and satisfaction levels. RESULTS: In the intention-to-treat (ITT) population, complete resolution occurred in 36 (18%) lesions total, 13 (21%) treated with HC, 12 (16%) with HC plus tobramycin and 11 (18%) with HC plus tobramycin/dexamethasone, with no significant difference between them (p = .78). Individually by paired t-test, there were statistically significant post-treatment mean size differences: HC 1.20 mm (p < 0.001), HC plus tobramycin 1.69 mm (p < .001) and HC plus tobramycin/dexamethasone 1.54 mm (p < 0.001), but no significant difference between them (p = .61). Lesions that completely resolved had a statistically significant lower pretreatment duration (1.5 months) compared to lesions that did not completely resolve (2.2 months) (p = .04). CONCLUSION: Hot compresses (HC) alone or in combination with tobramycin or tobramycin/dexamethasone drops and ointment are all effective first-line treatment options for chalazia. However, physicians may consider moving directly to the use of more invasive therapies, such as incision and curettage or steroid injections, for chalazia that have been present for more than 2 months, as older lesions are less likely to resolve with conservative therapies alone.