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TOPLINE:
A phospholipid nanoemulsion–based ocular lubricant applied twice daily is well tolerated, improves the stability of tear film, and alleviates symptoms in patients with dry eye disease.
METHODOLOGY:
Researchers conducted a prospective, multicenter, single-arm study in Brazil involving 70 adult patients (mean age, 45 years; 85.7% women) who were diagnosed with dry eye disease due to aqueous deficiency, evaporative dry eye, or a mixture of both conditions.
Patients were treated with the phospholipid nanoemulsion–based ocular lubricant twice daily for 28 days.
Clinical assessments included the measurement of the frequency and severity of dry eye disease using the Ocular Surface Disease Index (OSDI) symptom questionnaire, tear film break-up time, and corneal staining.
Patients were evaluated at four visits: Screening (days −7 to 0), baseline (day 1), mid-treatment (day 14), and end of treatment (day 28).
The primary endpoint was the safety and efficacy of the lubricant; the secondary efficacy endpoints included improvement in tear film break-up time and corneal staining after 14 and 28 days of treatment.
TAKEAWAY:
Total OSDI scores decreased significantly from 48.5 at baseline to 14 after 28 days of treatment (P < .0001), indicating a reduction in the severity of dry eye symptoms.
The lubricant significantly increased the mean tear film break-up time from 3.32 seconds at screening and baseline to 7.74 seconds on day 28 of treatment (P < .0001).
Corneal staining scores, measured using the vital dyes sodium fluorescein (P < .001) and lissamine green (P < .0001), decreased after 28 days of treatment, suggesting healing and protection of the corneal surface.
Overall, 73% patients reported no discomfort after using the eyedrops, with over half experiencing alleviation of symptom within minutes of application.
IN PRACTICE:
“The treatment of patients with DED [dry eye disease] with a phospholipid nanoemulsion–based ocular lubricant improved tear film stability and symptoms. This supports the hypothesis that the refurbishing of both aqueous and lipid layer with a nanoemulsion formula at a reduced frequency of instillation might be used as regimen therapy for patients with dry eyes,” the authors of the study wrote.
SOURCE:
The study was led by Maria Cristina Nishiwaki-Dantas, of the Department of Ophthalmology at the Federal University of São Paulo, São Paulo, Brazil. It was published online on November 1, 2024, in Ophthalmology and Therapy.
LIMITATIONS:
An objective measure of the lipid layer was not available due to the lack of specific equipment at all sites. The absence of a control group limited the comparisons with other treatments and the inference of the results to the study eyedrop only.
DISCLOSURES:
The study was funded by Alcon, which makes the eye drop. One author reported being an advisory board member of a pharmaceutical company. Another author reported receiving research funding and travel sponsorship and being an advisory board member of various pharmaceutical and medical device companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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