Dataset Information

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.

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.

SUBMITTER: Fogagnolo P

PROVIDER: S-EPMC7308118 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy and Safety of VisuEvo<sup>®</sup> and Cationorm<sup>®</sup> for the Treatment of Evaporative and Non-Evaporative Dry Eye Disease: A Multicenter, Double-Blind, Cross-Over, Randomized Clinical Trial.

Fogagnolo Paolo P Quisisana Chiara C Caretti Anna A Marchina Daniele D Dei Cas Michele M Melardi Ettore E Rossetti Luca L

Clinical ophthalmology (Auckland, N.Z.) 20200618

<h4>Purpose</h4>To compare the efficacy of the new lubricating product VisuEvo<sup>®</sup> (VSE) vs Cationorm<sup>®</sup> (CTN) in patients with dry eye disease (DED).<h4>Methods</h4>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, respectivel ...[more]

PMID: 32606580

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Dataset Information

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.

Purpose

Methods

Results

Conclusion

Study identifier

Publications

Efficacy and Safety of VisuEvo<sup>®</sup> and Cationorm<sup>®</sup> for the Treatment of Evaporative and Non-Evaporative Dry Eye Disease: A Multicenter, Double-Blind, Cross-Over, Randomized Clinical Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

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.

Purpose

Methods

Results

Conclusion

Study identifier

Publications

Efficacy and Safety of VisuEvo<sup>®</sup> and Cationorm<sup>®</sup> for the Treatment of Evaporative and Non-Evaporative Dry Eye Disease: A Multicenter, Double-Blind, Cross-Over, Randomized Clinical Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

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.