A Novel Liposome-Based, Aminoacid- and Vitamin-Containing Tear Substitute in Patients with Evaporative Dry Eye Disease. A Pilot Prospective Study
Year: 2021
Type: article
Study design: Clinical Trial
Abstract: Purpose.Dry eye disease (DED) is a common ocular disorder with a potentially severe impact on patients' quality of life.Tear substitutes are the first-line treatment.The aim of this pilot study was to collect preliminary data concerning the efficacy and safety of a new liposome-based tear substitute -Lacrisek Ofta Plus -enriched with L-proline, L-glycine, L-lysine hydrochloride, and L-leucine as well as vitamin A and E. Methods.Sixteen random-chosen eyes from as many consecutive patients (8 men and 8 women, mean age 55.8±16.2years) suffering from evaporative DED, confirmed by a positive InflammaDry test for MMP-9 pathologic levels, were treated using the investigational tear substitute for a 30-day period.The contralateral eye was treated with a different substitute whose use in the clinical setting was already documented.Changes in objective (tear film break-up time (TF-BUT), Oxford fluoresceine staining score, van Bijsterveld Lissamine green staining score, Meibomian glands score, InflammaDry test, conjunctival hyperemia) and subjective (Ocular Surface Disease Index (OSDI) score, burning, photophobia, foreign body sensation, itchy eyes, tearing) endpoints at the end of the treatment period were compared to those recorded beforetreatment.Results.After 30 days, eyes treated with the investigational device showed a significant improvement in the TF-BUT time (5.27±2.20 vs. 4.27±2.40seconds; p=0.007) and the Oxford fluoresceine staining score (1.82±0.98 vs. 2.27±0.90,p=0.019).Eyes positive to the InflammaDry test were significantly less (62.5 %) than those at baseline.Patients also reported a significant reduction of burning sensation at the treated eye.Conjunctival hyperemia showed a trend toward improvement.The OSDI and van Bijsterveld Lissamine green staining score, as well as other self-reported symptoms, did not change significantly.No patient suffered from any adverse effect. Conclusions.Within the limitations of the present study, Lacrisek Ofta Plus seems to be safe and effective in managing symptoms of dry eye disease, consistently with the beneficial effects ascribed to its liposome-based, aminoacid-and vitamin-containing formulation.Further studies are necessary to confirm these preliminary results.
Language: English
Subfield: Ophthalmology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4251802937