Journal List > J Korean Ophthalmol Soc > v.59(8) > 1099855

Shin, Bae, and Kim: The Effect of a Fixed Combination of 0.0015% Tafluprost-0.5% Timolol in Normal Tension Glaucoma Patients

Abstract

Purpose

This study evaluated the effect of a fixed combination of 0.0015% tafluprost-0.5% timolol (Tapcom®, Santen, Osaka, Japan) in glaucoma patients.

Methods

This study included 23 patients who were diagnosed with normal tension glaucoma and treated with a fixed combination of 0.0015% tafluprost-0.5% timolol as the first therapy. Diurnal intraocular pressure (IOP) was measured every 2 and 0.5 hours between 9:00 am and 4:30 pm. The IOP change with respect to body position (positional IOP) was measured at baseline and at 6 months after eye-drop instillations. IOP fluctuation was defined as the standard deviation of IOP measurements. Throughout the study, all side effects were recorded and monitored by the investigators.

Results

The mean reduction in IOP in the 0.0015% tafluprost-0.5% timolol fixed combination-treated eyes was −3.37 ± 2.39 mmHg (−19.70 ± 13.97%) for the right eye and −3.22 ± 2.27 mmHg (−18.81 ± 13.28%) for the left eye (paired t-test, p < 0.001). The mean positional IOP measured at 4 pm at 6 months after 0.0015% tafluprost-0.5% timolol fixed combination instillation showed statistically significant reduction from the mean positional IOP at baseline. There was a significant difference in the number of patients with ≤3 mmHg IOP variation over four time points between baseline and at 6 months in the 0.0015% tafluprost-0.5% timolol fixed combination-treated eyes (McNemar test, p < 0.001). There was no serious adverse event causing ocular damage.

Conclusions

Use of 0.0015% tafluprost-0.5% timolol fixed combination was effective and well tolerated in reducing IOP and in maintaining its effectiveness in glaucoma patients.

References

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Figure 1.
Mean intraocular pressure changes after 0.0015% ta-fluprost-0.5% timolol fixed combination instillation according to the time interval from baseline to month 6. The mean intraocular pressure at 1, 3, 6 months after 0.0015% tafluprost-0.5% timolol fixed combination instillation showed statistically significant reduction from the mean intraocular pressure at baseline.
jkos-59-752f1.tif
Table 1.
Profile and demographics of the patients (n = 23)
Number of final patients used TTFC Value
Mean age (years) 57.30 ± 12.09
Sex (male:female) (n, %) 18 (78.26):5 (21.74)
DM (n, %) 4 (17.39)
HTN (n, %) 8 (34.78)

Values are presented as mean ± standard deviation or n (%) unless otherwise indicated.

TTFC= tafluprost 0.0015%/timolol 0.5% fixed combination; DM = diabetes mellitus; HTN = hypertension.

Table 2.
Intraocular pressure (IOP) changes at 6 months after 0.0015% tafluprost-0.5% timolol fixed combination instillation from baseline
Diurnal IOP IOP (mmHg)
Measured IOP chan (mmHg) p-value*
At baseline At 6 months after eye-drop instillation
Right eye (n = 23)
 9:00 am 17.65 ± 2.53 13.91 ± 2.64 3.74 (20.48%) <0.001
 11:30 am 17.39 ± 2.92 13.87 ± 2.65 3.52 (19.49%) <0.001
 2:00 pm 17.09 ± 2.73 13.43 ± 1.80 3.65 (19.68%) <0.001
 4:30 pm 16.30 ± 3.02 13.70 ± 1.79 2.61 (13.13%) 0.002
 Mean 17.11 ± 2.42 13.74 ± 1.89 3.37 (19.70%) <0.001
 IOP fluctuation (Highest IOP-Lowest IOP) 3.30 ± 1.79 2.65 ± 1.47 0.203
Left eye (n = 23)
 9:00 am 17.83 ± 2.50 14.30 ± 2.05 3.52 (18.44%) <0.001
 11:30 am 17.04 ± 2.75 14.17 ± 2.29 2.87 (15.78%) <0.001
 2:00 pm 17.13 ± 2.28 13.61 ± 1.70 3.52 (19.40%) <0.001
 4:30 pm 16.48 ± 2.97 13.74 ± 2.00 2.74 (14.49%) <0.001
 Mean 17.12 ± 2.21 13.90 ± 1.73 3.22 (18.81%) <0.001
 IOP fluctuation (Highest IOP-Lowest IOP) 3.39 ± 1.78 2.39 ± 1.50 0.070

Values are presented as mean ± standard deviation or n (%) unless otherwise indicated.

% = percentage changes from baseline.

* Analyzed with the paired t-test.

Table 3.
Positional intraocular pressure (IOP) changes at 6 months after 0.0015% tafluprost-0.5% timolol fixed combination instillation from baseline (at 4:30 pm)
Position IOP (mmHg)
Measured IOP change (mmHg) p-value*
At baseline At 6 months after eye-drop instillation
Right eye (n = 14)
 Sitting 16.75 ± 1.40 13.36 ± 1.78 3.29 (18.81%) 0.001
 Supine 18.64 ± 2.06 15.14 ± 2.45 3.20 (16.14%) 0.002
 Right decubitus 19.41 ± 2.16 15.86 ± 2.74 3.13 (15.51%) 0.001
 Left decubitus 17.91 ± 2.22 13.79 ± 1.76 3.87 (20.63%) <0.001
 Mean 18.18. ± 2.29 14.54 ± 2.39 3.39 (18.06%) <0.001
Left eye (n = 14)
 Sitting 17.06 ± 2.22 13.36 ± 1.60 3.77 (21.20%) <0.001
 Supine 18.50 ± 2.52 15.43 ± 2.68 3.05 (15.26%) 0.004
 Right decubitus 17.88 ± 2.34 13.93 ± 2.06 3.88 (21.10%) <0.001
 Left decubitus 19.44 ± 2.44 16.29 ± 2.16 2.92 (14.74%) 0.006
 Mean 18.22 ± 2.49 14.75 ± 2.41 3.47 (17.85%) <0.001

Values are presented as mean ± standard deviation or n (%) unless otherwise indicated.

% = percentage changes from baseline.

* Analyzed with the paired t-test.

Table 4.
Intraocular pressure (IOP) fluctuation change after 0.0015% tafluprost-0.5% timolol fixed combination instillation from baseline to month 6
Instilled eye (n = 46) IOP fluctuation Baseline (n) Month 6 (n) p-value <0.001*
 ≤3 mmHg 24 39  
 >3 mmHg 22 7  

* Analyzed with McNemar test.

Table 5.
Mean intraocular pressure (IOP) changes after 0.0015% tafluprost-0.5% timolol fixed combination instillation according to the time interval from baseline to month 6
  Baseline– Month 1 Month 1– Month 3 Month 3– Month 6 Month 1– Month 6
Right eye (n = 15) −3.62 ± 0.85 0.53 ± 0.67 −0.13 ± 0.67 0.40 ± 0.41
p-value* 0.001* 0.438 0.846 0.341
Left eye (n = 15) p-value* −3.53 ± 0.80 0.001* 0.27 ± 0.42 0.535 −0.06 ± 0.53 0.906 0.20 ± 0.49 0.683

Values are presented as mean ± standard deviation unless otherwise indicated.

* Analyzed with the paired t-test, Bonferroni corrected.

Table 6.
Frequency and incidence of patients with adverse drug reactions
Patients with adverse drug reactions* Value
Pruritis 1 (4.35)
Burning sensation 1 (4.35)
Ocular hyperemia 2 (8.70)
Total 4 (17.39)

Values are presented as n (%).

* ‘Adverse drug reaction’ means ‘treatment-related adverse event’.

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