Comparison of the Effects of Dorzolamide/Timolol Fixed Combination versus Latanoprost on Intraocular Pressure and Ocular Perfusion Pressure in Patients with Normal-Tension Glaucoma: A Randomized, Crossover Clinical Trial

Abstract

BackgroudTo assess the noninferiority of a dorzolamide-timolol fixed combination (DTFC) versus latanoprost in terms of intraocular pressure (IOP) and to compare blood pressure (BP), ocular perfusion pressure (OPP) and diastolic ocular perfusion pressure (DOPP) between the latanoprost and DTFC groups in patients with normal-tension glaucoma (NTG).MethodsProspective, interventional, randomized, single-blinded, crossover design study. Patients with newly diagnosed NTG that had not been treated with a glaucoma medication in the most recent 2 months were recruited. In total, 44 patients with NTG were randomly allocated to one of two groups. Patients in group A were treated with DTFC, lubricant, and latanoprost for 4 weeks each, whereas patients in group B were treated with latanoprost, lubricant, and DTFC for 4 weeks each. Patients were examined on day 1 (without medication), week 4 (under medication), week 8 (without medication), and week 12 (under medication). At weeks 4 and 12, diurnal IOP, systolic and diastolic BP, and OPP were measured at 8:00 AM, 10:00 AM, 12:00 PM, 4:00 PM, and 8:00 PM.ResultsBaseline demographic characteristics showed no difference in terms of age, sex, central corneal thickness, spherical equivalent, or stage of glaucoma between the groups. The between-group difference was -0.19 ± 0.18 mmHg (mean ± SE, upper bound of one-sided 95% CI, 0.12). Diurnal IOP showed no difference between the groups with an average IOP reduction of 13.1% using latanoprost and 12.3% using DTFC. Diurnal systolic and diastolic BP were lower in the DTFC group than the latanoprost group; however, the difference between the groups was not statistically significant. Diurnal OPP and DOPP also showed no statistically significant difference between the groups.ConclusionsIOP lowering efficacy of DTFC was noninferior to that of latanoprost in newly diagnosed NTG patients. There was no difference in BP, OPP, or DOPP between the latanoprost and DTFC groups. This prospective, randomized, single-blinded, crossover study demonstrated the noninferiority of DTFC versus latanoprost in terms of IOP in patients with NTG.Trial RegistrationClinicalTrials.gov NCT01175902

Efficacy, Safety and Patient-Reported Outcomes with Preservative-Free (PF) Tafluprost or PF-Dorzolamide/Timolol Compared with Preserved Latanoprost: A Prospective Multicenter Study in Korean Glaucoma Patients with Ocular Surface Disease

“…The most common ocular treatment-related AEs in a study comparing dorzolamide/timolol (Cosopt ® ) with P-latanoprost were eye irritation (45.5% vs. 27.3%, respectively) and ocular hyperemia (4.5% vs.18.1%, respectively). Most AEs were mild in intensity and did not lead to study discontinuation [42], in line with the results reported in the current study. The two reported AEs (eye pruritus and blurred vision) for PF-tafluprost have been reported commonly (≥1/100 to <1/10) during clinical trials for this medication [43,45].…”

“…Although the rate of PRO improvement with PF-dorzolamide/timolol (35.3%) was over two-fold higher than that with P-latanoprost (16.7%), statistical significance was not reached. A double crossover study found that the IOP-lowering effect of fixed-combination dorzolamide/timolol (Cosopt ® ) was non-inferior to that of P-latanoprost in patients with glaucoma [42]. Similarly, in glaucoma patients switched to open-label PF-tafluprost, IOP was maintained at the same level as P-latanoprost [43].…”

Topical Medication Therapy for Glaucoma and Ocular Hypertension

“…DzT-FC does not exert systemic AEs and the most frequent ocular AEs are eye irritation and ocular hyperemia ( Kim et al, 2014 ; Lee et al, 2016b ; a ). PF-DzT-FC 1 improves local tolerability compared to DzT-FC ( Renieri et al, 2010 ; Shedden et al, 2010 ).…”

Diurnal and 24-h Intraocular Pressures in Glaucoma: Monitoring Strategies and Impact on Prognosis and Treatment

“…One study reported no effects on nocturnal IOP with topical β-antagonists in NTG eyes [ 151 ]. The effect of β-antagonist/CAI fixed combinations on diurnal IOP was reported to be similar to topical prostaglandins in NTG eyes [ 152 ]. Glaucoma filtering surgery significantly reduced the range of diurnal fluctuation [ 153 , 154 ].…”