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Disease etiology‐based design of multifunctional trehalose emulsion eye drops for moderate or severe dry eye: a randomised, quadruple‐masked and active‐controlled clinical trial
Author(s) -
Kaarniranta Kai,
Järvinen Riikka,
Wylegala Edward,
Laihia Jarmo
Publication year - 2019
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2019.5265
Subject(s) - medicine , ophthalmology , artificial tears , surgery
Purpose To assess the safety and efficacy of multi‐ingredient trehalose emulsion eye drops (TEED) designed to target (1) tear film instability, (2) tear hyperosmolarity, and (3) ocular surface damage and inflammation in moderate or severe dry eye. Methods This randomised, quadruple‐masked, active‐controlled parallel study in 64 adult patients comprised three parts. Part 1 ( n = 3): One eye was treated with TEED for one day. Part 2 ( n = 9): Randomised eyes were treated with TEED and 0.2% hyaluronic acid (HA) control eye drops 3 times a day for 10 days. Part 3 ( n = 26 + 26): Randomised treatment was applied on both eyes 3 times a day for 30 days. Ocular assessments were performed at baseline and after the last dose. Results Both treatments were well tolerated without adverse device effects. Tear film break‐up time (p = 0.0025) and ocular protection index (p = 0.0026; change vs. HA, p = 0.047) increased significantly with TEED after 30 days. Tear osmolarity decreased more in TEED than in HA group and significantly with both eye drops in hyperosmolar subgroups. Corneal (p = 0.014) and nasal conjunctival staining (p = 0.043) were reduced with TEED in per‐protocol patients ( n = 24). Conjunctival (p = 0.001) and lid redness (p = 0.012) decreased with TEED in all patients (n = 26). Symptoms decreased by about 25 OSDI units with both treatments (p < 0.0001). Conclusions TEED proved safe and efficacious in improving each etiologic factor for dry eye. Hyperosmolar stress dominating blink cycles must be disrupted by biophysical protection of the ocular surface to facilitate resolution of cellular damage and inflammation, and relief of ocular symptoms.