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

Abstract

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: Demodex; blepharitis; cleansing wipe; eyelid hygiene; hyaluronic acid; terpinen-4-ol.

Figure 1

Overall ocular discomfort. Mean (±SD) scores of the overall ocular discomfort as assessed using the 0–10 verbal numeric rating scale were plotted at each visit in Group 1 (1 daily application) (black bars) and in Group 2 (2 daily applications) (gray bars). Within-group differences from baseline were statistically significant in both groups; ***p<0.0001 vs baseline.

Figure 2

Scores of individual ocular symptoms. Each ocular symptom was rated overall for both eyes using a 0–10 verbal numeric rating scale at baseline, day 8, and day 29. Mean (±SD) scores are indicated for each symptom in Group 1 (1 daily application) (black bars) and Group 2 (2 daily applications) (gray bars).

Figure 3

Eyelid margin hyperemia. Mean (±SD) scores of eyelid margin hyperemia in the study eye as assessed using the 0–3 severity scale (0: none; 1: mild; 2: moderate; 3: severe) were plotted at each visit in Group 1 (1 daily application) (black bars) and Group 2 (2 daily applications) (gray bars). Within-group differences from baseline were statistically significant in both groups; **p<0.001 vs baseline, ***p<0.0001 vs baseline.

Figure 4

Cylindrical dandruff. Mean (±SD) number of cylindrical dandruff in the study eye were plotted at each visit in Group 1 (1 daily application) (black bars) and Group 2 (2 daily applications) (gray bars). Within-group differences from baseline were statistically significant in both groups; *p<0.01 vs baseline, **p<0.001 vs baseline, p=0.019 vs baseline.

Figure 5

Evolution of ocular signs at day 29. Changes from baseline to day 29 of each ocular sign in the study eye as assessed as “worsening”, “present and no change”, “none and no change”, and “improvement” are shown for Group 1 (1 daily application) and Group 2 (2 daily applications).

Figure 6

Patient’s questionnaire (user test) on day 29. Results of 5 questions posed to patients on the usability of the product with the responses "agree", "slightly agree", "slightly disagree", or "disagree" permitted in Group 1 (1 daily application) and Group 2 (2 daily applications).