Devices & drugs

A randomised trial of the eyelid device found no benefit over sham

BMC Ophthalmology, 21 November 2024 · volume 24, article 503 · doi 10.1186/s12886-024-03765-3

In November 2024 BMC Ophthalmology published a double-masked randomised placebo-controlled trial of BlephEx treatment for blepharitis. Forty-two patients whose symptoms had not responded to first-line treatment were assigned either to the device or to a sham procedure. After four weeks, the authors report, there was no significant difference between the two groups.

The authors describe the device as one that “provides automated eyelid debridement and aims to remove pathogenic biofilms from the eyelid margin to treat blepharitis long-term,” and they say at the outset that “evidence supporting the efficacy of BlephEx™ is limited.”

What was measured

Forty-two patients with symptomatic blepharitis refractory to treatment were assigned to the BlephEx treatment group or the sham treatment group. The outcome measures were the Ocular Surface Disease Index, tear break-up time, the Schirmer test and Efron grading scale scores, taken at baseline and again after four weeks. The groups were swapped after four weeks in a crossover design the authors describe as a recruitment tool. Two patients, one in each group, were lost to follow-up after receiving treatment.

What the trial found

In the authors’ words: “The sham group exhibited a significant decrease in the Efron Grading Scale score. No significant differences were observed in the other outcomes between the two groups.” The treated group showed slightly larger decreases in the Ocular Surface Disease Index and Efron scores, and a longer tear break-up time, than the sham group — “but these differences were not statistically significant.” Mild discomfort was the most common side effect and occurred equally in both groups.

The conclusion, in full: “No significant difference in outcomes was observed between patients who underwent BlephEx™ therapy and those who received sham treatment. BlephEx™ treatment cannot be recommended for treating blepharitis.”

What this is, and what it is not

This is one trial: forty-two patients, four weeks, a single centre’s protocol. It is not a regulatory finding, and it is a separate record from the warning letter FDA issued to the manufacturer in June 2026, which turns on marketing claims, reporting and quality systems rather than on clinical efficacy. A single negative trial does not settle a clinical question by itself. It is the published, peer-reviewed evidence that exists.

A claim that the device is the fix, the cure, or a way to treat is not permissible. A 2024 trial at the University of Freiburg found the powered eyelid-cleaning device was not shown to produce results statistically different from a sham procedure.

These notes paraphrase and quote one published, peer-reviewed trial. They are not legal advice and they are not medical advice.