Dataset Information

Efficacy and safety of latanoprost/timolol fixed combination dosed twice daily compared to once daily in patients with primary open angle glaucoma.

ABSTRACT:

Aim

To evaluate whether latanoprost/timolol fixed combination (LTFC) dosed twice daily may provide further intraocular pressure (IOP) reduction and evaluate the safety profile at this dose.

Methods

This is an open-labeled, randomized, prospective crossover study on fourty primary open angle glaucoma patients. Two weeks of washout period were followed by randomization to either once daily (OD, group A) or twice daily dosing (BD, group B) of LTFC for 4wk. After another 2-week washout period, the patients' treatment dose was crossed-over for another 4wk. IOP reduction alongside ocular and systemic side effects were evaluated.

Results

Mean baseline IOP was 18.57±2.93 and 17.8±3.01 mm Hg before OD and BD dose respectively, (P=0.27). Mean IOP after BD dose was statistically lower (12.49±1.59 mm Hg) compared to OD (13.48±1.81 mm Hg, P=0.017). Although IOP reduction after BD dose was more (5.32±3.24 mm Hg, 29.89%) than after OD dosing (5.04 mm Hg, 27.14%), it did not reach statistical significance (P=0.68). Patients switched from OD to BD (group A) showed mean IOP reduction by 0.69 mm Hg [95% confidence interval (CI): -0.09 to 1.48 mm Hg, P=0.078]; but patients switched from BD to OD (group B) had significantly higher mean IOP by 1.25 mm Hg (95%CI: -2.04 to -0.46 mm Hg, P=0.006). BD dose had more ocular side effects albeit mild.

Conclusion

Mean IOP after LTFC dosed twice daily is statistically lower, with additional mild side effects.

SUBMITTER: Azal AB

PROVIDER: S-EPMC10398532 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of latanoprost/timolol fixed combination dosed twice daily compared to once daily in patients with primary open angle glaucoma.

Azal Anis Baidura AB Hussein Siti Husna SH Tang Seng Fai SF Othman Othmaliza O Din Norshamsiah Md NM

International journal of ophthalmology 20230818 8

<h4>Aim</h4>To evaluate whether latanoprost/timolol fixed combination (LTFC) dosed twice daily may provide further intraocular pressure (IOP) reduction and evaluate the safety profile at this dose.<h4>Methods</h4>This is an open-labeled, randomized, prospective crossover study on fourty primary open angle glaucoma patients. Two weeks of washout period were followed by randomization to either once daily (OD, group A) or twice daily dosing (BD, group B) of LTFC for 4wk. After another 2-week washou ...[more]

PMID: 37602343

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Project description:PurposeTo compare the safety and efficacy of fixed-dose tafluprost/timolol combination (Taf/T-FDC) with those of fixed-dose latanoprost/timolol combination (Lat/T-FDC) by measuring the intraocular pressure (IOP)-lowering effect, ocular pharmacokinetics, and ocular surface toxicity.MethodsThe IOP-lowering effect of Taf/T-FDC and Lat/T-FDC in ocular normotensive monkeys was evaluated at 4 and 8 h after instillation in study A, at 12, 14, 16, and 18 h after instillation in study B, and at 24, 26, 28, and 30 h after instillation in study C. Drug penetration into the eye was evaluated by measuring the concentrations of timolol, tafluprost acid (active metabolic form of tafluprost), and latanoprost acid (active metabolic form of latanoprost) using liquid chromatography coupled with tandem mass spectrometry after single instillation of Taf/T-FDC or Lat/T-FDC to Sprague Dawley rats. Cytotoxicity following 1-30 min exposure of SV40-transformed human corneal epithelial cells to Taf/T-FDC or Lat/T-FDC was analyzed using 3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H-tetrazolium assays. Undiluted and 10-fold diluted solutions of each FDC were evaluated.ResultsThe IOP-lowering effect of Taf/T-FDC was almost equivalent to that of Lat/T-FDC at 4-8 h after instillation. The peak IOP reduction of Taf/T-FDC and Lat/T-FDC was observed at 8 h after instillation, and there is no difference between the two. The difference between them was observed at 24-30 h after instillation, and Taf/T-FDC demonstrated a significantly greater IOP-lowering effect than Lat/T-FDC at 24-30 h after instillation. The IOP-lowering effect of Taf/T-FDC was sustained up to 30 h after instillation, while that of Lat/T-FDC had almost disappeared at 28 h after instillation. Timolol concentrations in aqueous humor after Taf/T-FDC instillation were higher than those after Lat/T-FDC instillation (Cmax, 3870 ng/mL vs 1330 ng/mL; AUCinf, 3970 ng·h/mL vs 1250 ng·h/mL). The concentrations of tafluprost acid and latanoprost acid in aqueous humor after instillation of Taf/T-FDC and Lat/T-FDC, respectively, were similar to those after instillation of mono-preparations of tafluprost and latanoprost, respectively. The cytotoxic effect of Taf/T-FDC to the human corneal epithelial cells was significantly lower than that of Lat/T-FDC at all evaluated time points in both undiluted and 10-fold diluted FDCs.ConclusionTaf/T-FDC provides increased IOP-lowering effect duration and lower potential ocular surface toxicity than Lat/T-FDC.

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Project description:ObjectiveTo assess ocular discomfort upon instillation and patient preference for brinzolamide/timolol relative to dorzolamide/timolol, in patients with open-angle glaucoma or ocular hypertension.MethodsThis was a multicenter, prospective, patient-masked, randomized, crossover study. On day 0, patients received one drop of brinzolamide/timolol in one eye and one drop of dorzolamide/timolol in the contralateral eye. On day 1, patients were randomly assigned to receive one drop of either brinzolamide/timolol or dorzolamide/timolol in both eyes; on day 2, patients received one drop of the alternate treatment in both eyes. Measures included a patient preference question on day 2 (primary) and mean ocular discomfort scale scores on days 1 and 2 (secondary). Safety assessments included adverse events, visual acuity, and slit-lamp examinations.ResultsOf 120 patients who enrolled, 115 completed the study. Of these, 112 patients instilled both medications and expressed a study medication preference on day 2. A significantly greater percentage preferred brinzolamide/timolol to dorzolamide/timolol (67.0% versus 30.4%; P < 0.001). The ocular discomfort (expressed as mean [standard deviation]) with brinzolamide/timolol was significantly lower than with dorzolamide/timolol (day 2:1.9 [2.3] versus 3.7 [2.8], respectively [P = 0.0003]; both days combined: 2.1 [2.5] versus 3.5 [2.9], respectively [P = 0.00014]). On day 1, five patients receiving brinzolamide/timolol reported five nonserious adverse events (AEs): flu (n = 1), bitter taste (n = 2), and headache (n = 2). Four events, bitter taste (two events) and headache (two events), were considered related to brinzolamide/timolol. Events were mild in intensity, except bitter taste of moderate intensity reported by one patient. No AEs were reported at day 2. All AEs resolved without additional treatment. No clinically relevant changes from baseline were observed in best-corrected visual acuity or slit-lamp examinations of ocular signs.ConclusionPatients had less discomfort with brinzolamide/timolol than with dorzolamide/timolol, and more expressed a preference for brinzolamide/timolol. Both treatments were generally safe and well tolerated.

Dataset Information

Efficacy and safety of latanoprost/timolol fixed combination dosed twice daily compared to once daily in patients with primary open angle glaucoma.

Aim

Methods

Results

Conclusion

Publications

Efficacy and safety of latanoprost/timolol fixed combination dosed twice daily compared to once daily in patients with primary open angle glaucoma.

Similar Datasets

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