Sodium hyaluronate 0.30% ocular gel versus sodium hyaluronate 0.18% eye drop in the treatment of moderate to severe dry eye disease.

PURPOSE: Compare 0.30% sodium hyaluronate (0.30%HA) ocular gel with 0.18%HA eye drops in terms of improvement of ocular signs and symptoms, in patients with moderate to severe dry eye disease (DED). METHODS: This was a multicentric, randomized, investigator-masked, non-inferiority, comparative study conducted over 84 days. Three visits were scheduled, testing fluorescein corneal and conjunctival staining (Oxford and Van Bijsterveld scores), tear film break-up time (TBUT), Schirmer test, DED symptoms, 5-Item-Dry-Eye-Questionnaire (5-DEQ), patient and investigator satisfaction and frequency of instillation. RESULTS: At Day 35 (D35) and Day 84 (D84), both groups (n = 35 each) had a significant improvement in corneal staining (p < 0.001) with no inter-group difference. Van Bijsterveld score improved earlier (D35) for 0.30%HA suggesting a faster effect on conjunctival epithelium healing. There was no difference between the two concentrations in terms of TBUT or Schirmer improvements; however, the Schirmer test increase was only significant for 0.30%HA at D35 (p = 0.040). At D35 and D84, both groups showed similar improvements of DED symptoms and DEQ-5 score. Furthermore, treatment satisfaction was similar for the 2 formulations suggesting that daily use of 0.30%HA do not cause gel-related blurred vision disturbances. Frequency of instillation was similar for both groups. CONCLUSION: Our study demonstrates the non-inferiority of 0.30%HA gel compared to 0.18%HA solution in patients with moderate to severe DED. Because of its gel formulation and higher HA concentration providing prolonged comfort without causing visual disturbances, 0.30%HA gel might be adapted for bedtime use or during the day in more severe conditions.

A high-emollient liquid cleanser for very dry and atopic-prone skin: Results of an in-use tolerance and efficacy study conducted under dermatological, pediatric, and ophthalmological supervision.

BACKGROUND: Emollients play a key role in the treatment of eczematous lesions and xerosis such as in atopic dermatitis. However, studies that show the actual benefits of cleansers are few and far between. AIMS: This study aims to evaluate the tolerance and efficacy of a high-emollient liquid cleanser (HELC) designed for very dry and atopic-prone skin, in the absence of any additional skin care. The product is a soap-free and fragrance-free liquid cleanser, containing mild surfactants and a ternary system of selected emollients: glycerin, vaseline, and paraffin. METHODS: In-use study was conducted under dermatological, pediatric, and ophthalmological supervision in 50 subjects (infants, children, and adults) with "dry to very dry and atopic-prone" skin. The primary objective of this monocentric, open, and intra-individual study was to assess the dermatological and ophthalmological tolerance of HELC after 21 days of using it at least once a day on the face and body. The secondary objectives were to evaluate its efficacy based on a clinical score (SCORAD), assess its short- and long-term moisturizing effect by measuring hydration rates (Corneometer® ), and ascertain its cosmetic acceptability through a subjective evaluation questionnaire. RESULTS: The study validates the good dermatological and ophthalmological tolerance of HELC. Its efficacy was demonstrated by improvements in the SCORAD and moisturizing scores. Furthermore, the product was very well accepted by the subjects. CONCLUSION: The fragrance-free HELC tested in this study for 21 days on "dry to very dry and atopic-prone skin" improves skin dryness and pruritus while ensuring good tolerance.