Real-Life Study on the Efficacy and Tolerance of a Preservative-Free Surfactant-Free Latanoprost Eye Drop in Patients with Glaucoma

Abstract

Introduction: The purpose of this study is to assess the real-life efficacy and tolerance of a new preservative-free, surfactant-free latanoprost (PFSF-LAT) formulation.

Methods: Retrospective, multicentre, non-comparative, observational study in patients with ocular hypertension or open angle glaucoma, naïve or non-naïve to previous intraocular pressure (IOP)-lowering treatment, and treated for at least 3 months with the study eye drop. IOP for worse eye, ocular signs and symptoms, and concomitant use of artificial tears were collected at study drug initiation and at last visit under treatment. Reasons for discontinuing the study eye drop (if relevant) and investigators' satisfaction were also assessed.

Results: In the per protocol population (103 eyes; 63 naïve, 39 switched, 1 not classified because of missing data), IOP decreased significantly (p < 0.001) from 21.6 ± 5.0 mmHg at baseline to 16.1 ± 3.5 mmHg at the end of the study (mean reduction of - 5.5 ± 4.6 mmHg; - 25.5%). IOP in naïve patients was significantly improved, with a mean reduction of 7.1 mmHg (- 30.7%), which was within expected latanoprost IOP-lowering effect. Interestingly, in previously treated patients, switching to PFSF-LAT also allowed for a further 2.9 mmHg decrease in IOP (p < 0.001). The incidence of ocular side effects at study initiation was significantly (p < 0.001) reduced from 31.1% to 11.3% in the overall population, and from 65.0% to 7.5% in switched patients. This included conjunctival hyperaemia and superficial punctate keratitis (from 42.5% to 2.5% and from 37.5% to 2.5% in switched patients, respectively). According to investigators, tolerance and efficacy of the study eye drop were satisfactory or very satisfactory in 98.1% and 83.2% of patients, respectively.

Conclusion: PFSF-LAT is an efficient treatment for patients with glaucoma with an improved tolerance profile. It can be considered as initial therapy in naïve patients or in patients with poor ocular tolerance to previous IOP-lowering eye drops.

Keywords: Adherence; Efficacy; Glaucoma; Intraocular pressure; Latanoprost; Preservative-free; Real-life study; Surfactant-free; Tolerance.

Fig. 1

Trial inclusion flow chart. N stands for number

Fig. 2

Changes in IOP between initiation of the study eye drop and end of follow-up in the per protocol population. IOP was determined before and after at least 3 months of treatment with the study drug in the worse eye in the PP population (103 eyes) (*p < 0.001, paired t test). IOP intraocular pressure, N number, PP per protocol

Fig. 3

Ocular signs and symptoms in the overall study population (N = 107). Ocular signs (A) and ocular symptoms (B) were determined before and after the study drug initiation. The percentage of patients with at least one sign or one symptom was compared before and after the study drug initiation. (*p < 0.001, Wilcoxon signed ranks test). N number

Fig. 4

Ocular signs and symptoms in the switched patients (N = 40). Ocular signs (A) and ocular symptoms (B) were determined before and after the study drug initiation. The percentage of switched patients with at least one sign or one symptom was compared before and after the study drug initiation. (*p < 0.001, Wilcoxon signed ranks test). N number

Fig. 5

Frequency of artificial tears/lubricants in switched patients. In switched patients who used artificial tears/lubricants (N = 18), the frequency of artificial tears (number of instillations per day) was compared before and after the study drug initiation and showed a significant reduction after the study drug initiation (p = 0.034, Wilcoxon signed rank test). N number

Fig. 6

Investigator’s satisfaction in the overall study population