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; Chiara Quisisana; Anna Caretti; Daniele Marchina; Michele Dei Cas; Ettore Melardi; Luca Rossetti

doi:10.2147/OPTH.S258081

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

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

Authors

Paolo Fogagnolo¹, Chiara Quisisana¹, Anna Caretti², Daniele Marchina¹, Michele Dei Cas², Ettore Melardi¹, Luca Rossetti¹

Affiliations

¹ Eye Clinic ASST Santi Paolo Carlo, Department of Health Sciences, San Paolo Hospital, University of Milan, Milan, Italy.
² Department of Health Sciences, Laboratory of Biochemistry, University of Milan, Milan, Italy.

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.

Associated data

ClinicalTrials.gov/NCT03833882

Grants and funding

This study has been supported by private financial funding by Visufarma S.p.A., Rome, Italy). This statement faithfully reflects the authors’ declaration that each of contributing author has not had/has not/will have no financial or proprietary interest in the product studied in the present trial.