Efficacy and Safety of VisuEvo® and Cationorm® for the Treatment of Evaporative and Non-Evaporative Dry Eye Disease: A Multicenter, Double-Blind, Cross-Over, Randomized Clinical Trial
| العنوان: | Efficacy and Safety of VisuEvo® and Cationorm® for the Treatment of Evaporative and Non-Evaporative Dry Eye Disease: A Multicenter, Double-Blind, Cross-Over, Randomized Clinical Trial |
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| المؤلفون: | Anna Caretti, Chiara Quisisana, Luca Rossetti, Michele Dei Cas, Ettore Melardi, Daniele Marchina, Paolo Fogagnolo |
| المصدر: | Clinical Ophthalmology (Auckland, N.Z.) |
| بيانات النشر: | Dove, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Cross over, medicine.medical_specialty, ocular surface, business.industry, Ocular Surface Disease Index questionnaire, Significant difference, Glaucoma, medicine.disease, law.invention, tear break-up time, Double blind, Ophthalmology, Patient satisfaction, glaucoma, Blurred vision, Randomized controlled trial, law, medicine, medicine.symptom, business, meibomian gland disturbance, Ocular surface, evaporative dry eye disease, Original Research |
| الوصف: | Purpose To compare the efficacy of the new lubricating product VisuEvo® (VSE) vs Cationorm® (CTN) in patients with dry eye disease (DED). Methods Seventy-two patients with evaporative (n=54) and non-evaporative DED (n=18) were included in a multicenter, double-blind, 12-week cross-over study to receive VSE (6 weeks) and CTN (6 weeks) in randomized sequence. After baseline, two visits were performed during each period (intermediate and final visit, respectively at 2 and 6 weeks from the beginning of each period). Primary (tear break-up time, TBUT) and secondary endpoints (Schirmer I, Ferning, blink rate, osmometry, cytokine and lipid expression, ocular surface staining, patient satisfaction, and OSDI score) were compared. Results Sixty-three patients were evaluated for efficacy and 68 patients for safety. The intergroup differences for mean TBUT values were not significant at any study visit (baseline 3.2 ±1.5 sec; intermediate visits 4.5 ± 1.9 and 4.5 ± 1.8 sec in VSE and CTN groups, respectively, p = 0.10; final visits 5.4 ± 2.4 and 6.0 ± 3.1, respectively, p=0.63). Also, the assessment of secondary endpoints showed no significant difference between the two groups. The two study treatments were equally effective in evaporative and non-evaporative DED. The safety profile was excellent for both ocular treatments; transient blurred vision was observed in 11 patients only during CTN, 10 patients only during VSE, and 16 during both treatments. Conclusion VSE was non-inferior to CTN in restoring tear film composition, increasing its stability and reducing ocular surface damage in evaporative and non-evaporative DED patients. Study identifier NCT03833882. |
| اللغة: | English |
| تدمد: | 1177-5483 1177-5467 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::368f5d301e1af24629eba3327ab2e2e0 http://europepmc.org/articles/PMC7308118 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....368f5d301e1af24629eba3327ab2e2e0 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 11775483 11775467 |
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