Improvement in ocular symptoms and signs in patients with Demodex anterior blepharitis using a novel terpinen-4-ol (2.5%) and hyaluronic acid (0.2%) cleansing wipe
Authors Messaoud R, El Fekih L, Mahmoud A, Ben Amor H, Bannour R, Doan S, Khairallah M
Received 18 December 2018
Accepted for publication 3 April 2019
Published 20 June 2019 Volume 2019:13 Pages 1043—1054
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Colin Mak
Peer reviewer comments 3
Editor who approved publication: Dr Scott Fraser
Riadh Messaoud,1 Lamia El Fekih,2,3 Anis Mahmoud,1 Hager Ben Amor,4 Radhouane Bannour,5 Serge Doan,6,7 Moncef Khairallah4
1Department of Ophthalmology, Tahar Sfar University Hospital, Mahdia, Tunisia; 2Department of Ophthalmology, Internal Security Forces Hospital, La Marsa, Tunisia; 3Faculty of Medicine, Tunis-El Manar University, Tunis, Tunisia; 4Fattouma Bourguiba University Hospital, Monastir, Tunisia; 5Ophthalmology Private Practice, Monastir, Tunisia; 6Department of Ophthalmology, Bichat Hospital, Paris, France; 7Fondation A de Rothschild, Paris, France
Purpose: To evaluate the clinical improvement in ocular symptoms and signs in patients suffering from Demodex anterior blepharitis after using a novel cleansing wipe impregnated with 2.5% terpinen-4-ol and 0.2% hyaluronic acid.
Study design: This was an exploratory, multicenter, open, randomized, two-parallel group comparative study.
Methods: Forty-eight patients with Demodex anterior blepharitis were randomly assigned to apply the sterile wipe T1172 (Blephademodex®), either once daily (n=24, Group 1) or twice daily (n=24, Group 2) for 29 days. Overall ocular discomfort and other individual symptoms were measured using a 0–10 numeric rating scale at Day 8 and Day 29. Ocular signs, including eyelid margin hyperemia and number of cylindrical dandruff, were examined at slit lamp. Overall treatment performance by investigator, patient satisfaction and tolerance were evaluated with questionnaires.
Results: Overall ocular discomfort was significantly reduced from baseline (p<0.0001) in both groups at Day 8 (−3.6±0.3 in Group 1 and −4.0±0.4 in Group 2) and Day 29 (−5.7±0.4 and −6.8±0.7, respectively), with no difference between groups (D8: p=0.718; D29: p=0.505). Each ocular symptom associated with Demodex blepharitis was improved in both groups. Eyelid margin hyperemia was significantly reduced at Day 8 (−0.7±0.7; p<0.001) and Day 29 (−1.1±0.7; p<0.0001) in Group 1. Similar results were observed in Group 2 (Day 8: p<0.001; Day 29: p<0.0001). Total disappearance of cylindrical dandruff was reported in 30.4% of patients in Group 1 and 43.5% in Group 2. Improvements in other ocular signs were observed in both groups. The product was well tolerated. All patients were satisfied or very satisfied and would continue using it.
Conclusion: Daily eyelid hygiene using this cleansing wipe impregnated with 2.5% terpinen-4-ol and 0.2% hyaluronic acid during a 4-week period led to a rapid and marked reduction in ocular symptoms and signs associated with Demodex anterior blepharitis and was well tolerated.
Keywords: blepharitis, cleansing wipe, Demodex, eyelid hygiene, terpinen-4-ol, hyaluronic acid
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