Citation: Filippelli, M.; Campagna,
G.; Ciampa, N.; Fioretto, G.; Giannini,
R.; Marino, P.F.; dell’Omo, R.;
Costagliola, C. Ocular Tolerability of
Bimatoprost 0.1 mg/mL Preservative-
Free versus Bimatoprost 0.1 mg/mL
with Benzalkonium Chloride or
Bimatoprost 0.3 mg/mL Preservative-
Free in Patients with Primary
Open-Angle Glaucoma. J. Clin. Med.
2022, 11, 3518. https://doi.org/
10.3390/jcm11123518
Academic Editor: Jose Javier
Garcia-Medina
Received: 11 April 2022
Accepted: 17 June 2022
Published: 19 June 2022
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Journal of
Clinical Medicine
Article
Ocular Tolerability of Bimatoprost 0.1 mg/mL Preservative-Free
versus Bimatoprost 0.1 mg/mL with Benzalkonium Chloride or
Bimatoprost 0.3 mg/mL Preservative-Free in Patients with
Primary Open-Angle Glaucoma
Mariaelena Filippelli
1,
*
,†
, Giuseppe Campagna
2,†
, Nicola Ciampa
3
, Gaetano Fioretto
3
, Roberta Giannini
4
,
Pier Franco Marino
3
, Roberto dell’Omo
1
and Ciro Costagliola
1,3
1
Department of Medicine and Health Sciences, “V. Tiberio”, University of Molise, 86100 Campobasso, Italy;
roberto.dellomo@unimol.it (R.d.); ciro.costagliola@unimol.it (C.C.)
2
Department of Medical-Surgical Sciences and Translational Medicine, University of Rome “Sapienza”,
00185 Rome, Italy; gius.campagna@gmail.com
3
Department of Neurosciences, Reproductive Sciences and Dentistry, University of Naples Federico II,
80138 Naples, Italy; nicolaciampa3@gmail.com (N.C.); fioretto.gaetano@gmail.com (G.F.);
alpapini@tiscali.it (P.F.M.)
4
Department of Ophthalmology, San Camillo Hospital, 00152 Rome, Italy; robertagiannini1@gmail.com
* Correspondence: oftelena@gmail.com
† These authors contributed equally to this work.
Abstract: This study aimed to evaluate whether the therapeutic switch from a formulation of Bimato-
prost 0.1 mg/mL with benzalkonium chloride (BAK) or Bimatoprost 0.3 mg/mL preservative-free
to a formulation of Bimatoprost 0.1 mg/mL preservative-free could improve eye surface conditions
in patients with glaucoma; intraocular pressure (IOP) was also evaluated. All patients meeting the
inclusion criteria were eligible for the therapeutic switch to Bimatoprost 0.1 mg/mL preservative-
free. At each check visit, enrolled patients underwent a break-up time (BUT) test, an ocular surface
disease index (OSDI) test, and a three-point tonometric curve. A total of 40 patients were enrolled
(23 were in therapy with Bimatoprost 0.1 mg/mL with BAK and 17 with Bimatoprost 0.3 mg/mL
preservative-free). Significant differences of OSDI and BUT between Bimatoprost 0.1 mg/mL with
BAK at baseline vs. Bimatoprost 0.1 mg/mL preservative-free at 14 and 28 days (p < 0.0001 and
p = 0.0003, respectively) were recorded. Similarly, significant differences of OSDI and BUT between
Bimatoprost 0.3 mg/mL preservative-free at baseline vs. Bimatoprost 0.1 mg/mL preservative-free
at 14 and 28 days (p < 0.0001 for both) were found. Bimatoprost 0.1 mg/mL preservative-free has a
better tolerability profile associated with non-therapeutical inferiority in the control of IOP compared
to the other Bimatoprost formulations.
Keywords: primary open-angle glaucoma; bimatoprost; benzalkonium chloride; break-up time (BUT)
test; ocular surface disease index (OSDI); intraocular pressure (IOP)
1. Introduction
Glaucoma is defined as a group of irreversible, progressive optic neuropathies that can
lead to severe visual field loss and blindness [1]. Primary open-angle glaucoma (POAG)
is the most widespread type of glaucoma in European and African populations [2]. It
is estimated that 57.5 million people worldwide suffer from POAG and it is expected
that this number will reach 111.8 million by 2040 [3]. The reduction in light scattered
by the retinal nerve fiber layer (RFNL) near the optic nerve head is assumed to be an
early indicator of axonal degeneration and a sensitive way to identify glaucomatous
damage [4,5]. Several risk factors for glaucoma onset are known, such as age, gender,
family history of glaucoma, genetics, race (no white ethnicity), myopia, pseudoexfoliation,
J. Clin. Med. 2022, 11, 3518. https://doi.org/10.3390/jcm11123518 https://www.mdpi.com/journal/jcm