Slightly even more patients in the latanoprost plus timolol group (33% best eye, 32% still left eye) had OHT weighed against the fixed-dose combination group (25% best eye, 27% still left eye), latanoprost group (20% best eye, 19% still left eye), and timolol group (22% for every eye)

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Slightly even more patients in the latanoprost plus timolol group (33% best eye, 32% still left eye) had OHT weighed against the fixed-dose combination group (25% best eye, 27% still left eye), latanoprost group (20% best eye, 19% still left eye), and timolol group (22% for every eye). end factors were evaluated at three period points on trips at weeks 1, 2, 4, and 6 versus baseline. Outcomes The IOP-lowering efficiency from the fixed-dose mix of latanoprost/timolol was very similar compared to that of latanoprost plus timolol implemented concomitantly in any way time factors (indicate IOP difference and 95% self-confidence period within 1.5 mmHg; check for ordinal factors. All tests had been two-tailed, using a significance degree of 0.05. Repeated-measures evaluation of variance was useful for the principal end stage (modification in IOP from baseline). All statistical analyses had been performed using SAS? software program edition 9.1.3 (SAS Institute Inc., Cary, NC, USA). Outcomes Patients A complete of 300 sufferers had been screened at 17 sites in India. Of the, 227 sufferers fulfilled the eligibility requirements and had been randomized to 1 from the four treatment groupings: a fixed-dose mix of latanoprost/timolol (n=56), concomitant latanoprost plus timolol (58 sufferers), latanoprost by itself (n=55), and timolol by itself (n=58). Individual disposition is proven in Body 1. Of the sufferers, 216 (95.2%) completed the analysis. Of the rest of the eleven (4.8%) sufferers who discontinued from the analysis, the reason why were shed to follow-up (latanoprost/timolol, n=2; latanoprost, n=1), main process violation (latanoprost plus timolol, n=1; latanoprost, n=1), drawback of consent (latanoprost plus timolol, n=1; latanoprost, n=1), undesirable occasions (latanoprost, n=1 [corneal disorder]; timolol, n=1 [bradycardia]), individual non-compliance (latanoprost plus timolol, n=1), and failing of study medicine (timolol, n=1). All 227 sufferers randomized to get treatment were regarded as the protection inhabitants. The intent-to-treat inhabitants (efficacy evaluation inhabitants) contains 221 sufferers, as well as the per-protocol inhabitants contains 215 sufferers. Open in another window Body 1 Individual disposition. Records: aThe 227 randomized sufferers represented the protection inhabitants, including all sufferers who received at least one dosage of study medicine. bITT inhabitants (efficacy evaluation inhabitants) included all sufferers with baseline go to evaluation who received at least one dosage of study medicine with least one on-therapy efficiency evaluation. Missing data had been treated by last observation transported forward. cPP inhabitants included sufferers with at least one on-therapy efficiency assessment no main process violation. Abbreviations: ITT, purpose to take care of; PP, per process; N/n, number. Individual demographics, baseline features, and baseline IOP from the intent-to-treat inhabitants are proven in Desk 1. The entire mean inhabitants age group was 55.013.53 (range 20C83) years within this exclusively Asian individual population, and nearly all sufferers were male (67.0%). Significantly, there is no statistically factor in baseline IOP beliefs between your four treatment groupings, including a mean baseline IOP selection of 25.792.84 mmHg to 26.863.50 mmHg. Furthermore, there have been no statistically significant distinctions in the amount of sufferers with a brief history of OAG between your treatment groupings. Slightly more sufferers in the latanoprost plus timolol group (33% correct eye, 32% still left eye) got OHT weighed against the fixed-dose mixture group (25% correct eye, 27% still left eyesight), latanoprost group (20% correct eye, 19% still left eyesight), and timolol group (22% for every eye). This variation in OHT between your combined groups had not been thought to be getting statistically significant. Table 1 Individual demographic and baseline features (ITT inhabitants)* thead th align=”still ITIC left” valign=”best” rowspan=”2″ colspan=”1″ Category /th th colspan=”12″ align=”still left” valign=”best” rowspan=”1″ Treatment group hr / /th th align=”still left” valign=”best” rowspan=”2″ colspan=”1″ General (n=221) /th th colspan=”3″ align=”still left” valign=”best” rowspan=”1″ Latanoprost/timolol fixed-dose mixture (n =55) /th th colspan=”3″ align=”still left” valign=”best” rowspan=”1″ Latanoprost + timolol (n=56) /th th colspan=”3″ align=”still left” valign=”best” rowspan=”1″ Latanoprost (n=54) /th th colspan=”3″ align=”still left” valign=”best” rowspan=”1″ Timolol (n=56) /th /thead Sex, n (%)?Man39 (70.9)38 (67.9)36 (66.7)35 (62.5)148 (67.0)?Feminine16 (29.1)18 (32.1)18 (33.3)21 (37.5)73 (33.0)Age (years)?Mean56.353.556.254.055.0?SD14.3012.5914.3812.9313.53?Range24C8322C7220C7823C7720C83Iris color, n (%)?Dark brown55 (100.0)56 (100.0)53 (98.1)56 (100.0)220 (99.5)?Hazel001 (1.9)01 (0.5)Mean baseline IOP (mmHg)a9 am11 am5 pm9 am11 am5 pm9 am11 am5 pm9 am11 am5 pm?Mean26.3826.4825.9326.8126.2226.1626.2526.5925.7926.8626.4326.20?SD2.803.133.192.422.672.812.693.112.843.503.612.98?Range20.33C35.0020.00C37.6619.33C36.0019.67C33.3319.33C32.3320.00C34.0020.66C34.0018.00C36.0018.33C34.0019.66C39.0016.00C37.0019.33C35.00? em P /em -valueb0.39420.64580.68700.79830.84820.81260.43180.93750.6403?Difference?0.420.25?0.230.13?0.110.14?0.480.05?0.27?95% CI?1.41 to 0.56?0.84 to at least one 1.35?1.36 to 0.90?0.91 to at least one 1.18?1.30 to at least one 1.07?1.01 to at least one 1.28?1.67.cPP population included individuals with at least 1 on-therapy efficacy assessment no main protocol violation. Abbreviations: ITT, purpose to take care of; PP, per process; N/n, number. Individual demographics, baseline features, and baseline IOP from the intent-to-treat population are shown in Desk 1. time factors (mean IOP difference and 95% self-confidence period within 1.5 mmHg; check for ordinal factors. All tests had been two-tailed, using a significance degree of 0.05. Repeated-measures evaluation of variance was useful for the principal end stage (modification in IOP from baseline). All statistical analyses had been performed using SAS? software program edition 9.1.3 (SAS Institute Inc., Cary, NC, USA). Outcomes Patients A complete of 300 sufferers had been screened at 17 sites in India. Of the, 227 sufferers fulfilled the eligibility requirements and had been randomized to 1 from the four treatment groupings: a fixed-dose mix of latanoprost/timolol (n=56), concomitant latanoprost plus timolol (58 sufferers), latanoprost by itself (n=55), and timolol by itself (n=58). Individual disposition is proven in Body 1. Of the sufferers, 216 (95.2%) completed the analysis. Of the rest of the eleven (4.8%) sufferers who discontinued from the analysis, the reason why were shed to follow-up (latanoprost/timolol, n=2; latanoprost, n=1), main process violation (latanoprost plus timolol, n=1; latanoprost, n=1), drawback of consent (latanoprost plus timolol, n=1; latanoprost, n=1), undesirable occasions (latanoprost, n=1 [corneal disorder]; timolol, n=1 [bradycardia]), individual non-compliance (latanoprost plus timolol, n=1), and failing of study medicine (timolol, n=1). All 227 sufferers randomized to get treatment were considered as the safety population. The intent-to-treat population (efficacy analysis population) consisted of 221 patients, and the per-protocol population consisted of 215 patients. Open in a separate window Figure 1 Patient disposition. Notes: aThe 227 randomized patients represented the safety population, which included all patients who received at least one dose of study medication. bITT population (efficacy analysis population) included all patients with baseline visit assessment who received at least one dose of study medication and at least one on-therapy efficacy assessment. Missing data were treated by last observation carried forward. cPP population included patients with at least one on-therapy efficacy assessment and no major protocol violation. Abbreviations: ITT, intent to treat; PP, per protocol; N/n, number. Patient demographics, baseline characteristics, and baseline IOP of the intent-to-treat population are shown in Table 1. The overall mean population age was 55.013.53 (range 20C83) years in this exclusively Asian patient population, and the majority of patients were male (67.0%). Importantly, there was no statistically significant ITIC difference in baseline IOP values between the four treatment groups, which included a mean baseline IOP range of 25.792.84 mmHg to 26.863.50 mmHg. In addition, there were no statistically significant differences in the number of patients with a history of OAG between the treatment groups. Slightly more patients in the latanoprost plus timolol group (33% right eye, 32% left eye) had OHT compared with the fixed-dose combination group (25% right eye, Fosl1 27% left eye), latanoprost group (20% right eye, 19% left eye), and timolol group (22% for each eye). This variation in OHT between the groups was not regarded as being statistically significant. Table 1 Patient demographic and baseline characteristics (ITT population)* thead th align=”left” valign=”top” rowspan=”2″ colspan=”1″ Category /th th colspan=”12″ align=”left” valign=”top” rowspan=”1″ Treatment group hr / /th th align=”left” valign=”top” rowspan=”2″ colspan=”1″ Overall (n=221) /th th colspan=”3″ align=”left” valign=”top” rowspan=”1″ Latanoprost/timolol fixed-dose combination (n =55) /th th colspan=”3″ align=”left” valign=”top” rowspan=”1″ Latanoprost + timolol (n=56) /th th colspan=”3″ align=”left” valign=”top” rowspan=”1″ Latanoprost (n=54) /th th colspan=”3″ align=”left” valign=”top” rowspan=”1″ Timolol (n=56) /th /thead Sex, n (%)?Male39 (70.9)38 (67.9)36 (66.7)35 (62.5)148 (67.0)?Female16 (29.1)18 (32.1)18 (33.3)21 (37.5)73 (33.0)Age (years)?Mean56.353.556.254.055.0?SD14.3012.5914.3812.9313.53?Range24C8322C7220C7823C7720C83Iris color, n (%)?Brown55 (100.0)56 (100.0)53 (98.1)56 (100.0)220 (99.5)?Hazel001 (1.9)01 (0.5)Mean baseline IOP (mmHg)a9 am11 am5 pm9 am11 am5 pm9 am11 am5 pm9 am11 am5 pm?Mean26.3826.4825.9326.8126.2226.1626.2526.5925.7926.8626.4326.20?SD2.803.133.192.422.672.812.693.112.843.503.612.98?Range20.33C35.0020.00C37.6619.33C36.0019.67C33.3319.33C32.3320.00C34.0020.66C34.0018.00C36.0018.33C34.0019.66C39.0016.00C37.0019.33C35.00? em P /em -valueb0.39420.64580.68700.79830.84820.81260.43180.93750.6403?Difference?0.420.25?0.230.13?0.110.14?0.480.05?0.27?95% CI?1.41 to 0.56?0.84 to 1 1.35?1.36 to 0.90?0.91 to 1 1.18?1.30 to 1 1.07?1.01 to 1 1.28?1.67 to 0.72?1.22 to 1 1.32?1.43 to 0.89 Open in a separate window Notes: *Data shown are for the efficacy analysis (ITT) population. aMean IOP at baseline is for the study eye only. b em P /em -value was calculated for each group compared with latanoprost/timolol fixed-dose combination at the corresponding time point, using unpaired Students em t /em -test. Abbreviations: CI, confidence interval; IOP, intraocular pressure; ITT,.Administration of therapies with simple regimens is critical in encouraging long-term use of an effective ITIC ocular hypotensive agent that might delay or prevent glaucomatous damage.46 The evidence suggests that poor adherence is an issue in patients treated with complex medication regimens for glaucoma.47C51 This finding is supported by studies in patients with other chronic conditions (human immunodeficiency virus, diabetes, hypertension) that suggest adherence to medical therapy is higher in patients receiving fixed-dose combination regimens versus those receiving unfixed concomitant therapies.21 Similar advantages of topical fixed combinations might be expected in the treatment of glaucoma. time points (mean IOP difference and 95% confidence interval within 1.5 mmHg; test for ordinal variables. All tests were two-tailed, with a significance level of 0.05. Repeated-measures analysis of variance was used for the primary end point (change in IOP from baseline). All statistical analyses were performed using SAS? software version 9.1.3 (SAS Institute Inc., Cary, NC, USA). Results Patients A total of 300 patients were screened at 17 sites in India. Of these, 227 patients met the eligibility criteria and were randomized to one of the four treatment groups: a fixed-dose combination of latanoprost/timolol (n=56), concomitant latanoprost plus timolol (58 patients), latanoprost alone (n=55), and timolol alone (n=58). Patient disposition is shown in Figure 1. Of these patients, 216 (95.2%) completed the study. Of the remaining eleven (4.8%) patients who discontinued from the study, the reasons were lost to follow-up (latanoprost/timolol, n=2; latanoprost, n=1), major protocol violation (latanoprost plus ITIC timolol, n=1; latanoprost, n=1), withdrawal of consent (latanoprost plus timolol, n=1; latanoprost, n=1), adverse events (latanoprost, n=1 [corneal disorder]; timolol, n=1 [bradycardia]), patient noncompliance (latanoprost plus timolol, n=1), and failure of study medication (timolol, n=1). All 227 patients randomized to receive treatment were considered as the safety population. The intent-to-treat population (efficacy analysis population) consisted of 221 patients, and the per-protocol population consisted of 215 patients. Open in a separate window Figure 1 Patient disposition. Notes: aThe 227 randomized patients represented the safety population, which included all patients who received at least one dose of study medication. bITT population (efficacy analysis population) included all patients with baseline visit assessment who received at least one dose of study medication and at least one on-therapy efficacy assessment. Missing data were treated by last observation carried forward. cPP population included patients with at least one on-therapy efficacy assessment and no major protocol violation. Abbreviations: ITT, intent to treat; PP, per protocol; N/n, number. Patient demographics, baseline characteristics, and baseline IOP of the intent-to-treat population are shown in Table 1. The overall mean population age was 55.013.53 (range 20C83) years in this exclusively Asian patient population, and the majority of patients were male (67.0%). Importantly, there was no statistically significant difference in baseline IOP values between the four treatment groups, which included a mean baseline IOP range of 25.792.84 mmHg to 26.863.50 mmHg. In addition, there were no statistically significant differences in the number of patients with a history of OAG between the treatment groups. Slightly more patients in the latanoprost plus timolol group (33% right eye, 32% left eye) had OHT ITIC compared with the fixed-dose combination group (25% right eye, 27% left eye), latanoprost group (20% right eye, 19% left eye), and timolol group (22% for each eye). This variation in OHT between the groups was not regarded as being statistically significant. Table 1 Patient demographic and baseline characteristics (ITT population)* thead th align=”left” valign=”top” rowspan=”2″ colspan=”1″ Category /th th colspan=”12″ align=”left” valign=”top” rowspan=”1″ Treatment group hr / /th th align=”left” valign=”top” rowspan=”2″ colspan=”1″ Overall (n=221) /th th colspan=”3″ align=”left” valign=”top” rowspan=”1″ Latanoprost/timolol fixed-dose combination (n =55) /th th colspan=”3″ align=”left” valign=”top” rowspan=”1″ Latanoprost + timolol (n=56) /th th colspan=”3″ align=”left” valign=”top” rowspan=”1″ Latanoprost (n=54) /th th colspan=”3″ align=”left” valign=”top” rowspan=”1″ Timolol (n=56) /th /thead Sex, n (%)?Male39 (70.9)38 (67.9)36 (66.7)35 (62.5)148 (67.0)?Female16 (29.1)18 (32.1)18 (33.3)21 (37.5)73 (33.0)Age (years)?Mean56.353.556.254.055.0?SD14.3012.5914.3812.9313.53?Range24C8322C7220C7823C7720C83Iris color, n (%)?Brown55 (100.0)56 (100.0)53 (98.1)56 (100.0)220 (99.5)?Hazel001 (1.9)01 (0.5)Mean baseline IOP (mmHg)a9 am11 am5 pm9 am11 am5 pm9 am11 am5 pm9 am11 am5 pm?Mean26.3826.4825.9326.8126.2226.1626.2526.5925.7926.8626.4326.20?SD2.803.133.192.422.672.812.693.112.843.503.612.98?Range20.33C35.0020.00C37.6619.33C36.0019.67C33.3319.33C32.3320.00C34.0020.66C34.0018.00C36.0018.33C34.0019.66C39.0016.00C37.0019.33C35.00? em P /em -valueb0.39420.64580.68700.79830.84820.81260.43180.93750.6403?Difference?0.420.25?0.230.13?0.110.14?0.480.05?0.27?95% CI?1.41 to 0.56?0.84 to 1 1.35?1.36 to 0.90?0.91 to 1 1.18?1.30 to 1 1.07?1.01 to 1 1.28?1.67 to 0.72?1.22 to 1 1.32?1.43 to 0.89 Open in a separate window Notes: *Data shown are for the efficacy analysis (ITT) population. aMean IOP at baseline is for the study eye only. b em P /em -value was calculated for each group compared with latanoprost/timolol fixed-dose combination at the corresponding time point, using unpaired Students em t /em -test. Abbreviations: CI, confidence interval; IOP, intraocular pressure; ITT, intent to treat; SD, standard deviation. IOP assessments between treatment groups Significant reductions in IOP from baseline were observed in all treatment groups at all time points over the 6-week treatment period (Figure 2). The IOP reduction with the fixed-dose combination of latanoprost/timolol was similar to that with concomitant latanoprost plus timolol. Mean IOP in.