Journal
EUROPEAN JOURNAL OF OPHTHALMOLOGY
Volume 26, Issue 6, Pages 546-555Publisher
WICHTIG PUBLISHING
DOI: 10.5301/ejo.5000830
Keywords
Cationic emulsion; Dry eye; Ocular staining; Tear film
Categories
Funding
- Santen SAS, Evry, France
Ask authors/readers for more resources
Purpose: To evaluate the efficacy and safety of a preservative-free cationic emulsion (CE) with a 0.18% hyaluronate sodium (HS) solution in patients with moderate to severe dry eye disease (DED) with keratitis or keratoconjunctivitis. Methods: Eighty-five patients were randomized (1: 1) in this multicenter, prospective, reference-controlled, parallel-group, investigator-masked study to receive CE (n = 44) or HS (n = 41). Clinical signs and symptoms were assessed over 3 months. The primary efficacy endpoint was noninferiority of CE to HS in change from baseline of ocular surface staining (OSS) score at 1 month. Results: In the per protocol (PP) set and full analysis set (FAS), CE showed a similar and noninferior (p < 0.0001) improvement in OSS scores compared with HS at 1 month (PP: -2.5 +/- 1.3 vs -1.9 +/- 1.6; FAS: -2.2 +/- 1.5 vs -2.0 +/- 1.8 for CE vs HS). Other clinical signs of DED similarly improved in both groups. In the FAS, global symptoms score of ocular discomfort was significantly better with CE compared with HS at 1 month (-14.8 +/- 17.3 vs -7.6 +/- 14.2; p = 0.0469), including greater alleviation of itching (-14.8 +/- 21.2 vs -1.7 +/- 19.7; p = 0.0100) and eye dryness (-21.9 +/- 28.3 vs -8.4 +/- 21.4; p = 0.0016). Similar trends were observed at 3 months for itching and eye dryness. Investigator global efficacy assessment and quality of life scores for eye pain and driving favored CE at 3 months. Incidence of adverse events was low in both treatment groups. Conclusions: CE was similar to HS with regards to safety and efficacy for objective signs but was superior to HS in improving DED symptoms in patients with moderate to severe DED.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available