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1.  Predictors of additional intraocular pressure reduction in patients changed to latanoprost/timolol fixed combination 
BMC Ophthalmology  2010;10:10.
Given the growing number of ocular hypotensive medications available, it is important to be able to predict a positive response to therapy. The purpose of the present study was to identify predictors of an additional 10% intraocular pressure (IOP) reduction after 12 weeks of treatment with latanoprost/timolol fixed combination (FC) in patients requiring a change in their previous ocular hypotensive medication.
This multicenter, open-label, prospective, phase IIIb study included subjects ≥18 years of age with open-angle glaucoma (OAG) or ocular hypertension (OHT). Eligible subjects had baseline IOP ≥21 mmHg and insufficient response to current beta-blocker monotherapy. The primary efficacy analysis (logistic regression) identified predictors of a positive response after 12 weeks of latanoprost/timolol FC.
The intent-to-treat (ITT) population included 383 subjects treated with ≥1 drop of FC and having ≥1 follow-up IOP assessment. Mean IOP was 22.19 ± 2.16 mmHg at baseline and was reduced by 5.42 ± 2.71 mmHg at study end. In all, 325 (84.9%) subjects had a positive response to latanoprost/timolol FC; the response rate was similar across groups: OAG (n = 208; 82.7%); OHT (n = 161; 87.6%); OAG+OHT (n = 14; 85.7%). Higher baseline IOP (odds ratio: 1.284; 95% confidence interval [CI]: 1.101, 1.497; p = 0.0014) and absence of adverse events (odds ratio: 0.318; 95% CI: 0.161, 0.629; p = 0.0010) were significant predictors of positive response. Age, gender, ethnic origin, diagnosis, family history of OAG/OHT, corneal thickness, and concomitant systemic beta-blocker were not significant predictors of a positive response in the ITT analysis. The FC was well tolerated. The most common adverse events were related to the eye and were consistent with known adverse events associated with latanoprost and timolol.
These results support the use of latanoprost/timolol FC in patients whose IOP is insufficiently controlled on beta-blocker monotherapy. Patients with higher baseline IOP levels and who do not experience adverse events while on therapy are most likely to achieve a positive response to latanoprost/timolol FC.
Trial Registration
Study registration number: NCT00230763
PMCID: PMC2861019  PMID: 20346127
2.  First-line latanoprost therapy in ocular hypertension or open-angle glaucoma patients: a 3-month efficacy analysis stratified by initial intraocular pressure 
BMC Ophthalmology  2010;10:4.
Prospective, multicenter, randomized, double-masked trials have shown latanoprost instilled once daily to be at least as effective as and generally superior to timolol administered twice daily and to be as effective as other frequently prescribed prostaglandin analogues. This study prospectively assessed the efficacy of latanoprost monotherapy in a large cohort of treatment-naive patients with a broad range of baseline intraocular pressure (IOP) levels treated in actual clinical practice settings.
This prospective, open-label, multicenter, uncontrolled, phase IV study included treatment-naive ocular hypertension or open-angle glaucoma subjects initiating latanoprost once daily (evening). IOP levels were measured at baseline and after 1 and 3 months. The primary efficacy outcome was mean change in IOP from baseline to month 3. Analyses were stratified by baseline IOP: ≥ 20 and <24 mmHg vs ≥ 24 mmHg.
Efficacy analyses (intent to treat) included 572 subjects: 20 to <24 mmHg group, N = 252; ≥ 24 mmHg group, N = 320. Mean baseline IOP levels were 22.2 ± 0.9 mmHg and 26.7 ± 2.8 mmHg, respectively. At month 3, significant IOP reductions were seen in both groups (p < 0.0001, within-group differences); reductions were smaller in the 20 to <24 mmHg group (-6.3 ± 2.4 vs -9.2 ± 3.7 mmHg, respectively; -28.0 ± 10.6% vs -34.1 ± 11.9%, respectively). An IOP reduction of ≥ 30% from baseline to month 3 was noted in 48.4% and 65.6% of subjects, respectively (p < 0.0001). At month 3, targets IOPs of ≤ 18 mmHg were achieved by ≥ 70% of subjects in both groups. Latanoprost was well tolerated with an adverse event profile similar to that reported in the literature.
This "real world" study found once-daily latanoprost to be effective and safe in treatment-naive ocular hypertension or open-angle glaucoma patients. Patients with baseline IOP levels of 20 to <24 mmHg as well as ≥ 24 mmHg benefitted from initial latanoprost therapy.
Trial Registration
Trial Registration Number: NCT00647101
PMCID: PMC2841111  PMID: 20181282

Results 1-2 (2)