A 1-year randomized study of the clinical and confocal effects of tafluprost and latanoprost in newly diagnosed glaucoma patients

Paolo Fogagnolo, Angelica Dipinto, Elisa Vanzulli, Emanuele Maggiolo, Stefano De Cilla', Alessandro Autelitano, Luca Rossetti, Paolo Fogagnolo, Angelica Dipinto, Elisa Vanzulli, Emanuele Maggiolo, Stefano De Cilla', Alessandro Autelitano, Luca Rossetti

Abstract

Introduction: The aim of the present study was to compare the confocal and clinical features of newly diagnosed glaucoma patients receiving unpreserved prostaglandins (tafluprost) versus preserved prostaglandins (latanoprost).

Materials and methods: 40 patients were randomized to tafluprost 0.0015% (20 patients; 32 eyes) or latanoprost 0.005% + benzalkonium chloride 0.02% (20 patients; 35 eyes) once daily for 1 year. Inclusion criteria were new glaucoma diagnosis, and no ocular treatments for 6 months before the study. Patients were evaluated at baseline and every 3 months with a complete ophthalmologic evaluation, Schirmer's test, break-up time test, confocal microscopy of the central cornea, and measurement of intraocular pressure (IOP). Investigators were masked to treatment. Both eyes were analyzed if they fulfilled inclusion criteria. Treatments and changes between follow-up and baseline were compared by analysis of variance (ANOVA), t test and Chi-square test.

Results: At baseline, the two groups had similar age, ocular surface and confocal findings; keratocyte activation was present in 40%, branching pattern in 85%, and beading in 75%, with no inter-group differences. At follow-up, no significant clinical changes were detected, apart from a drop of IOP by 3.6-4.2 mmHg in the two groups (p < 0.001, with no difference between treatments). Despite inter-treatment ANOVA for confocal microscopy being negative, subtle changes were present. During follow-up, all eyes without nerve branching pattern at baseline progressively developed it when treated with latanoprost, whereas no change occurred using tafluprost treatment (p = 0.05). None of the eyes without beading at baseline developed it at the end of the study in the tafluprost group, whereas beading did occur in 75% of patients treated with latanoprost (p = 0.05). Both treatments were associated with increased keratocyte activation at follow-up; the change from baseline was statistically significant after month 3 with latanoprost (p = 0.02) and after month 6 with tafluprost (p = 0.04).

Conclusions: The two study treatments had similar clinical effects, but tafluprost had a more favorable profile for some confocal parameters of the cornea.

Funding: Merck Sharp & Dohme International.

Trial registration: ClinicalTrials.gov NCT01433900.

Figures

Fig. 1
Fig. 1
Confocal images of a patient treated with tafluprost. a Sub-basal plexus at baseline. b Sub-basal plexus at month 12: no relevant changes of density, length, morphology are shown. c Anterior stroma at baseline; no keratocyte activation is present. d Anterior stroma at month 12: no changes are shown; keratocyte activation is absent
Fig. 2
Fig. 2
Confocal images of a patient treated with latanoprost. a Sub-basal plexus at baseline. b Anterior stroma at baseline; no keratocyte activation is present. c Sub-basal plexus at month 12: disruption of normal nerve structure is shown: branching and beading are present, and nerve is tortuous; density is overall conserved. d Anterior stroma at month 12 showing keratocyte activation

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