Abstract
PURPOSE: To evaluate the safety and efficacy of a fixed combination (FC) of bimatoprost (BIM) and timolol (TIM) compared with each of the active components for 3 months. PATIENTS AND METHODS: Two double-masked, randomized, multicenter parallel studies of FC (once-daily, mornings), BIM (once-daily, evenings), or TIM (twice-daily) were conducted in 1061 patients with glaucoma or ocular hypertension. RESULTS: Mean diurnal decreases from baseline intraocular pressure (IOP) at month 3 were 8.1, 7.9, and 6.4 mm Hg for the FC, BIM, and TIM groups, respectively. The proportion of patients with a mean diurnal percent reduction from baseline in IOP of more than 20% across all visits was 81.8% (436/533), 72.1% (191/265), and 49.8% (131/263) for the FC, BIM, and TIM groups, respectively (P<0.001 for FC vs. BIM and FC vs. TIM). The proportion of patients achieving an IOP of less than 18 mm Hg at all time points was 39.2% (209/533), 28.7% (76/265), and 12.2% (32/263) for the FC, BIM, and TIM groups, respectively (P=0.003 for FC vs. BIM, and P<0.001 for FC vs. TIM). The most commonly reported treatment-related adverse event was conjunctival hyperemia, with the greatest incidence in BIM (38.5%, 102/265), followed by FC (22.7%, 121/533, P<0.0001 vs. BIM) and TIM (6.8%, 18/263; P<0.001 vs. FC). CONCLUSIONS: FC was statistically significantly more effective than BIM or TIM for most comparisons, and safer than BIM with respect to common ocular adverse events. FC represents a convenient, therapeutic advantage over separate bottles.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 211-216 |
| Number of pages | 6 |
| Journal | Journal of Glaucoma |
| Volume | 17 |
| Issue number | 3 |
| DOIs | |
| State | Published - Apr 2008 |
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Keywords
- Bimatoprost
- Fixed combination
- Glaucoma
- Intraocular pressure
- Timolol
ASJC Scopus subject areas
- Ophthalmology
Cite this
Bimatoprost/timolol fixed combination : A 3-month double-masked, randomized parallel comparison to its individual components in patients with glaucoma or ocular hypertension. / Brandt, James D; Cantor, Louis B.; Katz, L. Jay; Batoosingh, Amy L.; Chou, Connie; Bossowska, Izabella.
In: Journal of Glaucoma, Vol. 17, No. 3, 04.2008, p. 211-216.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Bimatoprost/timolol fixed combination
T2 - A 3-month double-masked, randomized parallel comparison to its individual components in patients with glaucoma or ocular hypertension
AU - Brandt, James D
AU - Cantor, Louis B.
AU - Katz, L. Jay
AU - Batoosingh, Amy L.
AU - Chou, Connie
AU - Bossowska, Izabella
PY - 2008/4
Y1 - 2008/4
N2 - PURPOSE: To evaluate the safety and efficacy of a fixed combination (FC) of bimatoprost (BIM) and timolol (TIM) compared with each of the active components for 3 months. PATIENTS AND METHODS: Two double-masked, randomized, multicenter parallel studies of FC (once-daily, mornings), BIM (once-daily, evenings), or TIM (twice-daily) were conducted in 1061 patients with glaucoma or ocular hypertension. RESULTS: Mean diurnal decreases from baseline intraocular pressure (IOP) at month 3 were 8.1, 7.9, and 6.4 mm Hg for the FC, BIM, and TIM groups, respectively. The proportion of patients with a mean diurnal percent reduction from baseline in IOP of more than 20% across all visits was 81.8% (436/533), 72.1% (191/265), and 49.8% (131/263) for the FC, BIM, and TIM groups, respectively (P<0.001 for FC vs. BIM and FC vs. TIM). The proportion of patients achieving an IOP of less than 18 mm Hg at all time points was 39.2% (209/533), 28.7% (76/265), and 12.2% (32/263) for the FC, BIM, and TIM groups, respectively (P=0.003 for FC vs. BIM, and P<0.001 for FC vs. TIM). The most commonly reported treatment-related adverse event was conjunctival hyperemia, with the greatest incidence in BIM (38.5%, 102/265), followed by FC (22.7%, 121/533, P<0.0001 vs. BIM) and TIM (6.8%, 18/263; P<0.001 vs. FC). CONCLUSIONS: FC was statistically significantly more effective than BIM or TIM for most comparisons, and safer than BIM with respect to common ocular adverse events. FC represents a convenient, therapeutic advantage over separate bottles.
AB - PURPOSE: To evaluate the safety and efficacy of a fixed combination (FC) of bimatoprost (BIM) and timolol (TIM) compared with each of the active components for 3 months. PATIENTS AND METHODS: Two double-masked, randomized, multicenter parallel studies of FC (once-daily, mornings), BIM (once-daily, evenings), or TIM (twice-daily) were conducted in 1061 patients with glaucoma or ocular hypertension. RESULTS: Mean diurnal decreases from baseline intraocular pressure (IOP) at month 3 were 8.1, 7.9, and 6.4 mm Hg for the FC, BIM, and TIM groups, respectively. The proportion of patients with a mean diurnal percent reduction from baseline in IOP of more than 20% across all visits was 81.8% (436/533), 72.1% (191/265), and 49.8% (131/263) for the FC, BIM, and TIM groups, respectively (P<0.001 for FC vs. BIM and FC vs. TIM). The proportion of patients achieving an IOP of less than 18 mm Hg at all time points was 39.2% (209/533), 28.7% (76/265), and 12.2% (32/263) for the FC, BIM, and TIM groups, respectively (P=0.003 for FC vs. BIM, and P<0.001 for FC vs. TIM). The most commonly reported treatment-related adverse event was conjunctival hyperemia, with the greatest incidence in BIM (38.5%, 102/265), followed by FC (22.7%, 121/533, P<0.0001 vs. BIM) and TIM (6.8%, 18/263; P<0.001 vs. FC). CONCLUSIONS: FC was statistically significantly more effective than BIM or TIM for most comparisons, and safer than BIM with respect to common ocular adverse events. FC represents a convenient, therapeutic advantage over separate bottles.
KW - Bimatoprost
KW - Fixed combination
KW - Glaucoma
KW - Intraocular pressure
KW - Timolol
UR - http://www.scopus.com/inward/record.url?scp=42149083759&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=42149083759&partnerID=8YFLogxK
U2 - 10.1097/IJG.0b013e3181507313
DO - 10.1097/IJG.0b013e3181507313
M3 - Article
C2 - 18414107
AN - SCOPUS:42149083759
VL - 17
SP - 211
EP - 216
JO - Journal of Glaucoma
JF - Journal of Glaucoma
SN - 1057-0829
IS - 3
ER -