Preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension

Figures & data

Table 1 Patient demographics

Subjects (n)	579
Age, years (mean [range])	58.1 (16–93)
Standard deviation	13.2
Sex, n (male/female/no data)	247/327/5
Diagnoses, n (%)
Ocular hypertension	105 (18.1)
Primary open-angle glaucoma	349 (60.3)
Normal tension glaucoma	71 (12.3)
Exfoliative glaucoma	27 (4.7)
Other glaucomas*	27 (4.7)

Notes:

* Other glaucomas include secondary glaucoma (n = 12), pigment dispersion (n = 2), glaucoma with narrow angle component (n = 3), and not specified (n = 10).

Table 2 Change in mean intraocular pressure (IOP) from baseline to final visit 12 weeks after initiation of medical therapy with preservative-free tafluprost

Diagnosis	n	Eyes, n (RE/LE)	Mean IOP at baseline, mmHg ± SD (range, mmHg)	Mean IOP at final visit, mmHg ± SD (range, mmHg)	Δ IOP baseline vs final visit (mmHg)	% change in IOP at baseline vs final visit	P*
All patients	579	347/232	23.6 ± 4.0 (6–38)	16.8 ± 2.9 (7–27)	−6.8	−28.8	<0.001
POAG	349	207/149	24.6 ± 2.9 (19–38)	17.3 ± 2.4 (10–25)	−7.3	−29.7	<0.001
OH	105	59/46	24.4 ± 2.6 (22–38)	17.5 ± 2.4 (12–27)	−6.9	−28.3	<0.001
NTG	71	49/22	16.6 ± 1.9 (6–19)	13.3 ± 2.4 (7–19)	−3.3	−19.9	<0.001
PEX	27	16/11	25.8 ± 3.5 (19–37)	17.5 ± 2.4 (10–22)	−8.3	−32.2	<0.001
OG	27	16/11	23.7 ± 5.4 (10–36)	16.7 ± 4.4 (9–26)	−7.0	−29.5	<0.001

Note:

* t-test for paired samples.

Abbreviations: Δ IOP, IOP at final visit minus IOP at baseline; LE, left eyes; NTG, normal tension glaucoma; OG, other glaucomas; OH, ocular hypertension; PEX, exfoliative glaucoma; POAG, primary open-angle glaucoma; RE, right eyes; SD, standard deviation.

Figure 1 Percentage intraocular pressure (IOP) reduction at final visit versus untreated baseline for different patient subgroups.

Notes: IOP reductions are classified into four categories: ≥10%, ≥20%, ≥30%, and ≥40%.
Abbreviations: NTG, normal tension glaucoma; OH, ocular hypertension; PEX, exfoliative glaucoma; POAG, primary open-angle glaucoma.

Figure 2 Achievement of specific intraocular pressure levels at final visit versus untreated baseline for different patient subgroups.

Abbreviations: NTG, normal tension glaucoma; OH, ocular hypertension; PEX, exfoliative glaucoma; POAG, primary open-angle glaucoma.

Figure 3 Achievement of specific intraocular pressure (IOP) levels at final visit versus untreated baseline in all patients with primary open-angle glaucoma (POAG) and ocular hypertension (OH) and in the two subgroups stratified by baseline IOP levels at month 3 after initiation of medical treatment.

Notes:^aP ≤ 0.05 for between-group difference: Chi-square test; ^bP < 0.0001 for between-group difference: Chi-square test.

Table 3 Intraocular pressure (IOP) ± standard deviation (SD) in patients with primary open-angle glaucoma and ocular hypertension at baseline and at month 3 after initiation of medical treatment

	Baseline IOP ≥ 20 to 23 mmHg (n = 172)	Baseline IOP ≥ 24 mmHg (n = 282)
Mean baseline IOP (mmHg) ± SD	21.9 ± 1.1	26.2 ± 2.4
IOP month 3 (mmHg) ± SD	16.5 ± 2.2	17.9 ± 2.4
Change in mean IOP from baseline to month 3 (mmHg) ± SD	5.4 ± 2.2	8.3 ± 3.0
P*	<0.0001	<0.0001
% change in IOP from baseline to month 3	24.7	31.7
≥10% IOP reduction from baseline to month 3, n (%)a	162 (94.2)	278 (98.6)
≥20% IOP reduction from baseline to month 3, n (%)b	120 (69.8)	258 (91.5)
≥30% IOP reduction from baseline to month 3, n (%)c	51 (29.7)	149 (52.8)
≥40% IOP reduction from baseline to month 3, n (%)d	8 (4.7)	50 (17.7)

Notes:

* t-test for paired samples.

a P = 0.119 for between-group difference; Chi-square test;

b P < 0.1 for between-group difference; Chi-square test;

c P < 0.0001 for between-group difference; Chi-square test;

d P < 0.003 for between-group difference; Chi-square test.

Figure 4 Local tolerability of preservative-free tafluprost at month 3 for all patients and for different patient subgroups.

Abbreviations: NTG, normal tension glaucoma; OH, ocular hypertension; PEX, exfoliative glaucoma; POAG, primary open-angle glaucoma.

Table 4 Adverse events and terminations of treatment

Adverse event/complaint	Diagnosis	Patients, n	Patients, %	Termination, n	Termination, %
Lack of IOP-lowering efficacy	POAG	4	0.7	3	0.5
	OH	1	0.2	0	0.0
	PEX	2	0.3	0	0.0
	NTG	1	0.2	1	0.2
	Other glaucomas	1	0.2	0	0.0
Conjunctival hyperemia	OH	2	0.3	1	0.2
	POAG	1	0.2	0	0.0
Hyperemia and eyelid hyperpigmentation	OH	1	0.2	1	0.2
Itching	POAG	1	0.2	1	0.2
Headache	POAG	1	0.2	1	0.2
Increased contrast sensitivity	POAG	1	0.2	1	0.2
Patient decision	NTG	2	0.3	2	0.3
Unknown	POAG	1	0.2	1	0.2
Total		19	3.3	12	2.1
Remaining on monotherapy after final visit (month 3)				567	97.9
Total				579	100.0

Abbreviations: NTG, normal tension glaucoma; OH, ocular hypertension; PEX, exfoliative glaucoma; POAG, primary open-angle glaucoma.