Abstract
BackgroundGiven 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.MethodsThis 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.ResultsThe 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.ConclusionsThese 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 RegistrationStudy registration number: NCT00230763
Highlights
Given the growing number of ocular hypotensive medications available, it is important to be able to predict a positive response to therapy
Subjects Male or female subjects ≥18 years of age diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT) with an intraocular pressure (IOP) ≥21 mmHg were eligible if they were being treated with an ophthalmic beta-blocker monotherapy and if, in the investigator's opinion, they required a change in ocular hypotensive therapy because of an insufficient response to treatment
Of the 98 major protocol deviations recorded in 70 subjects, 67 of whom were in the ITT population, most related to noncompliance with inclusion/exclusion criteria (n = 50), not using study drug at the time of IOP assessment (n = 20), or use of commercial latanoprost/timolol fixed combination (FC) during the study (n = 20)
Summary
Given the growing number of ocular hypotensive medications available, it is important to be able to predict a positive response to therapy. Latanoprost/timolol FC became commercially available in France in 2002 and is indicated for reduction of IOP in patients with OAG and OHT who are insufficiently responsive to monotherapy with topical beta-blockers or prostaglandin analogs [11]. This FC has been shown to be effective and well tolerated [12,13,14,15,16,17]. Given the growing number of ophthalmic medications available, our goal was to identify predictors of a positive response (i.e., an additional l0% IOP reduction) in patients with OAG or OHT who required a change in their previous ophthalmic medication and who were switched to latanoprost/timolol FC
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
