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. 2020 Jun 18:14:1651-1663.
doi: 10.2147/OPTH.S258081. eCollection 2020.

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

Paolo Fogagnolo  1 , Chiara Quisisana  1 , Anna Caretti  2 , Daniele Marchina  1 , Michele Dei Cas  2 , Ettore Melardi  1 , Luca Rossetti  1
Affiliations

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

Paolo Fogagnolo et al. Clin Ophthalmol. .

Abstract

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.

Keywords: Ocular Surface Disease Index questionnaire; evaporative dry eye disease; glaucoma; meibomian gland disturbance; ocular surface; tear break-up time.

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Conflict of interest statement

Paolo Fogagnolo and Luca Rossetti received honoraria for medical meetings and advisory board from Visufarma S.p.A, Rome, Italy. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Flow of the study design. After verifying eligibility at V1, patients received washout from lubricating treatments until V2. They then entered two 6-week periods. The first product was randomly assigned at V2, the second at V4. V3 and V5 were the intermediate visits of the first and second 6-week period, respectively. No washout occurred between V4 and V5.
Figure 2
Figure 2
Blandt–Altmann plot for comparison of baseline and final TBUT values between study treatments.
Figure 3
Figure 3
Blandt–Altmann plot for comparison of baseline and final OSDI scores between study treatments.
Figure 4
Figure 4
Changes of proportion (%) of patients with staining grade with fluorescein during the study visits with both ophthalmic solutions (VisuEvo® and Cationorm®).
Figure 5
Figure 5
Distribution of proportion (%) of patients during study visits, according to Ferning test grading scale, between the two treatment groups.
See this image and copyright information in PMC

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