Efficacy and safety of a lipid-containing artificial tear compared with a non-lipid containing tear: a randomized clinical trial.

Autor: Donnenfeld E; Ophthalmic Consultants of Long Island, Fairfield, CT, USA., Coats J; McDonald Eye Associates, Fayetteville, AR, USA., Barbour K; Bausch + Lomb, Inc., Rochester, NY, USA., Ryan R; Bausch + Lomb, Inc., Rochester, NY, USA., Joshi NR; Johnson & Johnson, New Brunswick, NJ, USA., Periman LM; Periman Eye Institute, Seattle, WA, USA. dryeyemaster@gmail.com.
Jazyk: angličtina
Zdroj: BMC ophthalmology [BMC Ophthalmol] 2024 Oct 08; Vol. 24 (1), pp. 442. Date of Electronic Publication: 2024 Oct 08.
DOI: 10.1186/s12886-024-03688-z
Abstrakt: Background: Dry eye disease (DED) is a prevalent condition affecting over 16 million patients in the USA. DED and the symptoms of ocular discomfort are debilitating and a significant burden on patients. If left untreated, DED can progress to cause severe pathology. Treatment is often initiated by patients without consulting a healthcare professional. This study investigated the safety and efficacy of a novel lipid-containing eye drop (BTC), which might better mimic the components of natural tears.
Methods: This was a multicenter, randomized, double-masked, active control, two arm, parallel group study of eye drops in adult subjects with self-reported DED. Subjects were randomly assigned to BTC or control (commercially available non-lipid eye drops; NLED) arm and were followed for 30 days. Assessments using visual analog scale and patient-reported outcomes (PRO) questionnaires, non-invasive tear break up time, slit-lamp examination, and subject-reported ocular symptoms were conducted at baseline and at days 7 and 30. The primary endpoint was change in overall ocular comfort score from baseline to day 30.
Results: 158 subjects were randomized, of whom 130 completed the study per protocol (PP). Mean (SD) age was 47.8 (14.14) years. The mean (95% CI) change in overall comfort scores at the 30-day follow-up in the PP population was 21.4 (15.1, 27.7) for the test drop and 10.0 (3.9, 16.1) for the comparator. The mean (95% CI) treatment difference was 11.3 (2.6, 20.1); this met the pre-defined requirements for non-inferiority. There was no significant difference in the proportion of eyes with reported ocular symptoms between the groups. At day 7, the OR (95% CI) was 0.967 (0.528, 1.770) and at day 30 was 1.160 (0.610, 2.203). There were no Grade 3 or higher corneal edema, corneal neovascularization, corneal staining, conjunctival injection, tarsal abnormalities or any other biomicroscopy findings, and no corneal infiltrates observed during the study.
Conclusions: The investigational lipid eye drop BTC was noninferior to the commercially available non-lipid comparator in all parameters measured and has the potential to provide an effective therapy for subjects with symptoms of dry eye who would benefit from a lipid-based artificial tear.
Trial Registration: NCT03995355 ( http://www.
Clinicaltrials: gov ), registered June 24, 2019.
(© 2024. The Author(s).)
Databáze: MEDLINE
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