The HaLF-DOME study was a prospective, multicenter, controlled, double-masked, randomised study to evaluate the efficacy and safety of Lacrifill® in treating chronic dry eye disease (DED) compared to Oasis Form Fit canalicular plugs.1

Primary endpoint

Non-inferiority of the mean change from baseline to month 3 in the Schirmer score (non-inferiority margin of 2.5 mm).1

Secondary endpoint

Non-inferiority of the proportion of patients achieving improvement from baseline to month 3 in OSDI score by a minimal clinically important difference.1

More details

Improvement in tear quantity sustained for 6 months

Lacrifill® met its primary endpoint of non-inferiority compared to Oasis Form Fit as measured by Schirmer test score at 3 months.

Lacrifill® demonstrated statistically significant improvement in Schirmer test score from baseline to Month 3 and Month 6.¹

Lacrifill® is a treatment that is proven to deliver sustained improvements for dry eye patients over 6 months.1

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Improvement in dry eye symptoms sustained for 6 months

Lacrifill® demonstrated significant improvement of symptoms of DED from baseline to month 3 and month 6.1

Lacrifill® is a treatment that delivers reliable symptom relief for up to 6 months.

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Achieve ocular surface control within 7 days with Lacrifill

Lacrifill® resulted in significant improvement in corneal staining from baseline to Day 7.2

Lacrifill® is a treatment that can give you rapid control over your patients’ ocular surface.

There was comparable incidence of ocular device-related AEs between treatment groups

Summary of adverse events (safety population)

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Parameter Lacrifill®
(n=103) n (%)		 Form Fit
(n=54) n (%)		 Total
(N=157) n (%)
Number of patients with ≥1 ocular device-related AE 26 (25.2) 14 (25.9) 40 (25.5)
Most common ocular device-related AEs
Eyelid pain 5 (4.9) 1 (1.9) 6 (3.8)
Epiphora 8 (7.8) 3 (5.6) 11 (7.0)
Blepharitis 2 (1.9) 1 (1.9) 3 (1.9)
Procedural pain 7 (6.8) 3 (5.6) 10 (6.4)

N=total number of patients in the respective treatment group. Percentages were based on the total number of patients in each treatment group. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA) 23.1. Patients experiencing >1 AE were counted once within that preferred term. Device-related AEs were those categorised as definite, probable, and possible.

Adapted from: Packer M, et al. 2024.¹

Read full publication of Lacrifill®

Read all information about the Lacrifill in the full publication.