A Randomized, Controlled Study of the Efficacy and Safety of a New Eyedrop Formulation for Moderate to Severe Dry Eye Syndrome
| Autor: | Moncef Khairallah, Christophe Baudouin, Riadh Messaoud, Marc Labetoulle, Nicolas Rocher, Serge Doan, Lamia El Fekih, Frédéric Chiambaretta |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male 0301 basic medicine Moderate to severe medicine.medical_specialty medicine.medical_treatment Dry Eye Syndromes law.invention Young Adult 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Surveys and Questionnaires Internal medicine Humans Medicine KERATOCONJUNCTIVITIS SICCA Schirmer test Hyaluronic Acid Aged Aged 80 and over business.industry Trehalose General Medicine Middle Aged Clinical trial Drug Combinations Ophthalmology Artificial tears Treatment Outcome 030104 developmental biology Multicenter study Patient Satisfaction 030221 ophthalmology & optometry Female France Ophthalmic Solutions business |
| Zdroj: | European Journal of Ophthalmology. 27:1-9 |
| ISSN: | 1724-6016 1120-6721 |
| Popis: | Purpose This study compared the efficacy and safety of hyaluronic acid (HA)-trehalose, a new eyedrop containing trehalose (a natural bioprotectant) and HA, to an established formulation containing only HA. Methods This was a phase III, randomized, active-controlled, investigator-masked, multicenter study in France and Tunisia. In all, 105 adult patients (≥18 years) with moderate to severe dry eye disease (DED) received either HA-trehalose (n = 52) or HA (n = 53) 3-6 times per day for 84 days. The primary efficacy variable was the Oxford grading score at day 35. A questionnaire on dry eye and symptoms, Schirmer test, tear break-up time, conjunctival hyperemia, and global performance were assessed as secondary efficacy criteria at baseline, day 35, and day 84. Safety assessments were standard. Results Noninferiority of HA-trehalose to HA for keratoconjunctivitis sicca assessed by Oxford grading score was demonstrated at day 35. For the secondary efficacy parameters, reductions in dry eye questionnaire classes of none or mild at day 84, dry eye symptoms of stinging, itching, and blurred vision at day 35, and investigator (days 35 and 84) and patient assessments (day 35) of global performance were significantly better for HA-trehalose. There were no clinically meaningful differences between groups for the other secondary criteria. Both treatments were well-tolerated, and there were fewer ocular symptoms upon instillation and fewer adverse events for HA-trehalose than for HA. Conclusions Hyaluronic acid-trehalose is effective and safe, with better patient satisfaction, than existing HA-only eyedrops particularly from the first month of treatment, and offers a therapeutic advancement in the treatment of moderate to severe DED. |
| Databáze: | OpenAIRE |
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