Sodium hyaluronate 0.30% ocular gel versus sodium hyaluronate 0.18% eye drop in the treatment of moderate to severe dry eye disease.
Eur J Ophthalmol
; 33(1): 188-195, 2023 Jan.
Article
in En
| MEDLINE
| ID: mdl-35450456
ABSTRACT
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Dry Eye Syndromes
/
Hyaluronic Acid
Type of study:
Clinical_trials
Limits:
Humans
Language:
En
Journal:
Eur J Ophthalmol
Journal subject:
OFTALMOLOGIA
Year:
2023
Document type:
Article
Affiliation country:
España