Better tolerance of preservative-free latanoprost compared to preserved glaucoma eye drops: the 12-month real-life FREE study

Figures & data

Table 1 Demographic and glaucoma data at inclusion

Variables	Prevalence Total N=721
Age (years)
n	716
Mean ± SD	66.6±10.92
Missing	5
Sex (%)
Female	59.2%
Male	39.7%
Missing	1.1%
Glaucoma type (%)
Primary	92.5%
Angle closure	0.5%
Open angle (high and low tension)	92.0%
Secondary	7.2%
Exfoliative	5.0%
Pigmentary	1.4%
Other	0.8%
Missing	2.1%
Glaucoma stages (%)
Early glaucoma (<6 dB)	38.6%
Moderate glaucoma (6–12 dB)	13.4%
Severe glaucoma (>12 dB)	2.4%
Missing	43.5%
Time since glaucoma diagnosis (years)
n	622
Mean ± SD	6.9±6.15
Missing	99
IOP (eyes merged, mmHg)
n	1414
Mean ± SD	17.3±3.68
Missing	28
Previous treatment(s) (%)
Yes	63.0%
No	37.0%
Number of patients who changed treatments and mean number of change
n	442
Mean ± SD	2.3±1.60
Missing	7

Figure 1 Intraocular pressure at inclusion, follow-up visit 1, and follow-up visit 2 of patients with preserved eye drops and preservative-free latanoprost eye drops.

Abbreviation: PF, preservative-free.

Figure 2 Prevalence of patients with no conjunctival hyperemia at inclusion, follow-up visit 1, and follow-up visit 2.

Note: The difference between the two treatment groups was statistically significant (P=0.0015) at all visits.
Abbreviation: PF, preservative-free.

Table 2 Patient-reported symptoms upon and between instillations at inclusion, follow-up visit 1, and follow-up visit 2

Symptoms	Inclusion visit		Follow-up visit 1		Follow-up visit 2
	Preserved treatments (%)	PF latanoprost (%)	Preserved treatments (%)	PF latanoprost (%)	Preserved treatments (%)	PF latanoprost (%)
(a) Upon instillation
No symptom	56.8	72.7	66.80	79.90	76.90	95.30
Blurred vision	9.1	8.2	5.20	7.70	7.50	2.30
Pain or discomfort	35.6	19.1	25.70	14.60	15.80	4.60
Missing	1.5	2.7	0.90	0	0.90	0
(b) Between instillations
No symptom	33.1	55.7	51.4	66.2	64.8	55.8
Burning	19.5	8.2	8.9	7.1	5.5	16.3
Dry eye sensation	20.2	15.3	9.8	12.4	14.8	14.0
Foreign body sensation	12.3	8.2	10.2	6.4	8.4	9.4
Itching	13.1	6.0	10.3	7.8	11.6	11.6
Photophobia	4.8	3.3	5.1	6.4	1.9	2.3
Red eye	29.1	11.5	13.3	6.5	10.2	7.0
Tingling	29.1	10.9	12.1	9.7	4.7	11.7
Watering	12.5	7.7	7.9	8.0	7.4	9.3
Missing	2.3	6.6	2.8	1.9	1.9	2.3

Abbreviation: PF, preservative-free.

Table S1 Local legal requirements followed for the conduct of the study

Countries	Health authorities	Ethical committee	Data protection agency	Insurance certificate required	Comments
France	CCTIRS (Comité Consultatif sur le Traitement de l’Information en matière de Recherche dans le domaine de la Santé)	No	CNIL (Commission Nationale de l’Informatique et des Libertés)	No
Poland	Not applicable	Approval from KOMISJA BIOETYCZNA (Centrum Medyczne Ksztalcenia Podyplomowego – Warszawa)	Local data privacy laws	Yes	Under the responsibility of the national coordinator
the Netherlands	SOP obtained for 5 years (2013–2018)	Approval from Stichting CGR (Amsterdam) and METC (Medische Ethische Toetsings Commissie – Erasmus MC)	Local data privacy laws	Yes	Non-WMO research studies
Norway	Norwegian Medicines Agency (NOMA)	Approval from REK (Regionale Komiteer for Medisinsk OG Helsefaglig Forkningsetikk)	Trial registered in a publicly accessible database	Yes	There are currently no requirements for non-investigational studies (NIS) to be approved by NOMA National code of practice: Pharmaceutical self-regulation body: The Association of the Pharmaceutical Industry in Norway (LMI) Guidelines for NIS of marketed medicines (March 2008)
Sweden	Approval from the Sveriges Kommuner och Landsting or SKL	Approval from Board for Ethics Review (EPN)	Local data privacy laws	Yes	There are currently no requirements for non-investigational studies (NIS) to be approved by MPA Pharmaceutical Self-Regulation Body: The Läkemedelsindustriföreningen known as “LIF”

Abbreviations: SOP, standard operating procedure; CGR, Code Geneesmiddelen Reclame; WMO, Wet medisch-wetenschappelijk onderzoek met mensen (Medical Research Involving Human Subjects Act); MPA, Swedish Medical Products Agency