The following is a summary of “Efficacy and safety of a lipid-containing artificial tear compared with a non-lipid containing tear: a randomized clinical trial,” published in the October 2024 issue of Ophthalmology by Donnenfeld et al.

Millions of people are generally affected by a common infection, dry eye disease (DED) leading to discomfort and potential severe pathology if untreated.   

Researchers conducted a retrospective study investigating the safety and efficacy of lipid-containing eye drops (BTC) designed to mimic natural tears.   

They examined adults with self-reported DED. Participants were randomly allocated to either the BTC arm or the control arm (commercially available non-lipid eye drops; NLED) and monitored for 30 days. Evaluations, including visual analog scale, patient-reported outcomes (PRO) questionnaires, non-invasive tear break-up time, slit-lamp examinations, and self-reported ocular symptoms, were performed at baseline, day 7, and day 30. The primary outcome was the overall ocular comfort score change from baseline to day 30.   

The results showed that 158 subjects were randomized, with 130 completing the study per protocol (PP). The mean (SD) age was 47.8 (14.14) years. In the PP population, the mean (95% CI) change in overall comfort scores at the 30-day follow-up 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 of 11.3 (2.6, 20.1) met the non-inferiority criteria. No significant difference was found in the proportion of eyes with reported ocular symptoms between the groups. On day 7, the OR (95% CI) was 0.967 (0.528, 1.770), and on day 30, it was 1.160 (0.610, 2.203). No Grade 3 or higher corneal edema, neovascularization, staining, conjunctival injection, tarsal abnormalities, or corneal infiltrates were observed.  

They concluded that the BTC was non-inferior to the NLED in all measured parameters and could effectively treat patients with DED symptoms needing lipid-based artificial tears. 

Source: bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-024-03688-z#Abs1