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Comparison of the effects of bimatoprost and a fixed combination of latanoprost and timolol on circadian intraocular pressure.
Ophthalmology 2007; 114(12):2244-51O

Abstract

OBJECTIVE

To compare the effect of bimatoprost and the fixed combination of latanoprost and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched from a nonfixed combination of latanoprost and timolol.

DESIGN

Randomized, double-masked, multicenter clinical trial.

PARTICIPANTS

Two hundred patients with glaucoma or ocular hypertension.

METHODS

Included were patients who were controlled (IOP < 21 mmHg) on the nonfixed combination of latanoprost and timolol for at least 3 months before the baseline visit or patients on monotherapy with either latanoprost or timolol who were eligible for dual therapy not being fully controlled on monotherapy. The latter group of patients underwent a 6-week wash-in phase with the nonfixed combination of latanoprost and timolol before baseline IOP determination and study inclusion. Supine and sitting position IOPs were recorded at 8 pm, midnight, 5 am, 8 am, noon, and 4 pm at baseline, week 6, and week 12 visits.

MAIN OUTCOME MEASURE

An analysis of covariance model was used for a noninferiority test of the primary efficacy variable, with mean area under the 24-hour IOP curve after 12 weeks of treatment as response variable and treatment, center, and baseline IOP as factors. A secondary analysis was performed on the within-treatment change from baseline.

RESULTS

Mean baseline IOPs were 16.3+/-3.3 mmHg and 15.5+/-2.9.mmHg in the bimatoprost and LTFC groups, respectively. At week 12, mean IOPs were 16.1+/-2.5 mmHg for the bimatoprost group and 16.3+/-3.7 mmHg for the LTFC group, and no significant difference between the 2 treatment groups could be found. As compared with baseline, mean IOP increased by 0.3+/-3.6 mmHg during the day and decreased by 0.8+/-3.8 mmHg during the night in the bimatoprost group, whereas there were increases of 1.43+/-2.6 mmHg and 0.14+/-3.2 mmHg in the LTFC group, respectively.

CONCLUSIONS

Bimatoprost is not inferior to the LTFC in maintaining IOP at a controlled level during a 24-hour period in patients switched from the nonfixed combination of latanoprost and timolol.

Authors+Show Affiliations

Clinica Oculistica, Dipartimento di Medicina, Chirurgia e Odontoiatria, Università di Milano, Ospedale San Paolo, Milan, Italy. lucamrossetti@libero.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17459480

Citation

Rossetti, Luca, et al. "Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol On Circadian Intraocular Pressure." Ophthalmology, vol. 114, no. 12, 2007, pp. 2244-51.
Rossetti L, Karabatsas CH, Topouzis F, et al. Comparison of the effects of bimatoprost and a fixed combination of latanoprost and timolol on circadian intraocular pressure. Ophthalmology. 2007;114(12):2244-51.
Rossetti, L., Karabatsas, C. H., Topouzis, F., Vetrugno, M., Centofanti, M., Boehm, A., ... Goldblum, D. (2007). Comparison of the effects of bimatoprost and a fixed combination of latanoprost and timolol on circadian intraocular pressure. Ophthalmology, 114(12), pp. 2244-51.
Rossetti L, et al. Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol On Circadian Intraocular Pressure. Ophthalmology. 2007;114(12):2244-51. PubMed PMID: 17459480.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of the effects of bimatoprost and a fixed combination of latanoprost and timolol on circadian intraocular pressure. AU - Rossetti,Luca, AU - Karabatsas,Costas H, AU - Topouzis,Fotis, AU - Vetrugno,Michele, AU - Centofanti,Marco, AU - Boehm,Andreas, AU - Viswanathan,Ananth, AU - Vorwerk,Christian, AU - Goldblum,David, Y1 - 2007/04/25/ PY - 2006/08/07/received PY - 2007/01/29/revised PY - 2007/01/29/accepted PY - 2007/4/27/pubmed PY - 2007/12/19/medline PY - 2007/4/27/entrez SP - 2244 EP - 51 JF - Ophthalmology JO - Ophthalmology VL - 114 IS - 12 N2 - OBJECTIVE: To compare the effect of bimatoprost and the fixed combination of latanoprost and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched from a nonfixed combination of latanoprost and timolol. DESIGN: Randomized, double-masked, multicenter clinical trial. PARTICIPANTS: Two hundred patients with glaucoma or ocular hypertension. METHODS: Included were patients who were controlled (IOP < 21 mmHg) on the nonfixed combination of latanoprost and timolol for at least 3 months before the baseline visit or patients on monotherapy with either latanoprost or timolol who were eligible for dual therapy not being fully controlled on monotherapy. The latter group of patients underwent a 6-week wash-in phase with the nonfixed combination of latanoprost and timolol before baseline IOP determination and study inclusion. Supine and sitting position IOPs were recorded at 8 pm, midnight, 5 am, 8 am, noon, and 4 pm at baseline, week 6, and week 12 visits. MAIN OUTCOME MEASURE: An analysis of covariance model was used for a noninferiority test of the primary efficacy variable, with mean area under the 24-hour IOP curve after 12 weeks of treatment as response variable and treatment, center, and baseline IOP as factors. A secondary analysis was performed on the within-treatment change from baseline. RESULTS: Mean baseline IOPs were 16.3+/-3.3 mmHg and 15.5+/-2.9.mmHg in the bimatoprost and LTFC groups, respectively. At week 12, mean IOPs were 16.1+/-2.5 mmHg for the bimatoprost group and 16.3+/-3.7 mmHg for the LTFC group, and no significant difference between the 2 treatment groups could be found. As compared with baseline, mean IOP increased by 0.3+/-3.6 mmHg during the day and decreased by 0.8+/-3.8 mmHg during the night in the bimatoprost group, whereas there were increases of 1.43+/-2.6 mmHg and 0.14+/-3.2 mmHg in the LTFC group, respectively. CONCLUSIONS: Bimatoprost is not inferior to the LTFC in maintaining IOP at a controlled level during a 24-hour period in patients switched from the nonfixed combination of latanoprost and timolol. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/17459480/Comparison_of_the_effects_of_bimatoprost_and_a_fixed_combination_of_latanoprost_and_timolol_on_circadian_intraocular_pressure_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(07)00119-4 DB - PRIME DP - Unbound Medicine ER -