Timogel® vs Timolol 0.5% Ophthalmic Solution: Efficacy, Safety, and Acceptance

2011 ◽  
Vol 22 (1) ◽  
pp. 28-33 ◽  
Author(s):  
Teresa Rolle ◽  
Daniela Curto ◽  
Camilla Alovisi ◽  
Mauro Franzone ◽  
Beatrice Brogliatti ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Side Effects ◽  
Open Angle Glaucoma ◽  
Ophthalmic Solution ◽  
Previous Treatment ◽  
Hypotensive Effect ◽  
Schirmer Test ◽  
Blurred Vision ◽  
Once Daily ◽  
Preservative Free

Purpose To evaluate the efficacy, safety, and tolerability of Timogel® preservative-free once daily compared to timolol 0.5% ophthalmic solution bid in patients with ocular hypertension (OHT) and patients with primary open-angle glaucoma (POAG). Methods A total of 75 patients with OHT and patients with POAG treated with timolol 0.5% bid with intraocular pressure (IOP) ≤21 mmHg were enrolled. They underwent complete ophthalmologic examination, IOP measurements (at trough and daytime curve), evaluation of side effects, Schirmer test, break-up time [BUT], blood pressure, heart rate, ocular diastolic perfusion pressure measurements, and acceptance (Comparison of Ophthalmic Medications for Tolerability). Patients switched to Timogel® and were re-evaluated 3 months later. The analysis of variance and the Pearson χ2 tests were used to test differences between the treatments. Results Intraocular pressure reduction at trough was 23.6% with timolol 0.5% and 22.3% with Timogel®. No statistical differences were observed in IOP values at trough and in the daytime curve between the 2 treatments. Local and systemic side effects were less frequent with Timogel® (hazard ratio: p<0.05). Patients demonstrated a significant improvement of Schirmer test and BUT (p<0.05) and a reduction of dryness and foreign body sensation (42.6% vs 15.4%; p<0.01) after switching to Timogel®. Mild and short-lasting blurred vision after Timogel® instillation occurred in about 18.5% of patients. A total of 82% of patients were satisfied or very satisfied with Timogel® vs 61% with previous treatment (p<0.01). Conclusions Timogel® preservative-free dosed once every morning has a 24-hour hypotensive effect with a better safety profile than timolol 0.5% bid and it is well-accepted by patients. The once-daily dosing improved acceptance and compliance.

scholarly journals Preservative-free versus preserved latanoprost eye drops for reducing intraocular pressure: a non-inferiority phase III randomized, multi-center, single-blind, parallel-group controlled trial

2021 ◽  
Vol 9 (4) ◽  
Author(s):  
Panos Theodosiadis ◽  
Anastasios Konstas ◽  
Ioannis Halkiadakis ◽  
Vasiliki Dimera ◽  
Dimitrios Koufakis ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Ocular Hypertension ◽  
Open Angle Glaucoma ◽  
Ophthalmic Solution ◽  
Phase Iii ◽  
Point Estimate ◽  
Eye Drops ◽  
Open Angle ◽  
Parallel Group ◽  
Preservative Free

Background: The aim of this study was to test the non-inferiority of preservative-free (PF) latanoprost 50 μg/mL multi-dose ophthalmic solution versus the marketed benzalkonium chloride (BAK)-preserved latanoprost 50 μg/mL ophthalmic solution in patients with open-angle glaucoma and patients with ocular hypertension. Methods: This was a prospective, national, randomized, multi-center, observer-blind, parallel-group controlled clinical trial. Patients were randomized to receive either PF or BAK-preserved latanoprost once daily for 12 weeks. The primary endpoint was the change in intraocular pressure (IOP) at 8:00 AM in the affected eye between the end of the treatment (week 12) and the baseline (week 0). Secondary measurements were taken at weeks 2 and 6, with IOP being recorded at 8:00 AM, 12:00 PM, and 4:00 PM. Results: A total of 158 patients were included in the per protocol (PP) population (77 in the PF latanoprost treatment arm and 81 patients in the BAK-preserved latanoprost treatment arm). PF latanoprost was non-inferior to BAK-preserved latanoprost in reducing IOP at 8:00 AM in the study eye from the baseline (week 0) to the end of the treatment (week 12). The point estimate of the between-treatment difference was 0.1 mmHg (95% confidence interval: -0.646, 0.847). Mean between-group differences in IOP reduction from the baseline to each of the secondary measurements were also similar between the two treatment arms. The two treatments were well tolerated and had comparable adverse event profiles. Conclusions: PF latanoprost was non-inferior to BAK-preserved latanoprost in reducing IOP in patients with open-angle glaucoma or ocular hypertension. Both treatments were well tolerated.

scholarly journals Non-inferiority evaluation of preservative-free latanoprost/timolol eye drops solution versus preserved latanoprost/timolol eye drops in patients with high intraocular pressure and open-angle glaucoma

2021 ◽  
Vol 9 (4) ◽  
Author(s):  
Panos Theodosiadis ◽  
Anastasios Konstas ◽  
Ioannis Halkiadakis ◽  
Vasiliki Dimera ◽  
Dimitrios Koufakis ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Open Angle Glaucoma ◽  
Ophthalmic Solution ◽  
Phase Iii ◽  
Point Estimate ◽  
Eye Drops ◽  
Open Angle ◽  
Local Tolerance ◽  
Safety Parameters ◽  
Preservative Free

Background: This study aimed to evaluate the non-inferiority and safety of a newly developed preservative-free (PF) multi-dose latanoprost/timolol ophthalmic solution, compared with the benzalkonium chloride (BAK)-preserved fixed combination, in patients with open-angle glaucoma and ocular hypertension.Methods: A Phase III randomized multi-center observer-blind parallel-group clinical trial was conducted. A total of 210 adult patients (aged over 18 years) were randomly treated with the PF- or the BAK-preserved latanoprost/timolol solution once daily in the affected eye(s) for 12 weeks. Follow-up visits were scheduled at weeks 2, 6, and 12; intraocular pressure (IOP) was recorded at 8:00 AM, 12:00 PM, and 4:00 PM. The primary efficacy endpoint to prove non-inferiority was the IOP change at 8:00 AM (± 1 hour) from the baseline to the end of treatment (week 12) in the studied eye. Safety parameters were also assessed.Results: In total, 196 patients completed the study. The pressure-lowering effect of the PF eye drops was comparable to that of the preserved formulation at all time points. Latanoprost/timolol PF formulation was non-inferior to the BAK-preserved solution as shown by the change in IOP from day 0 to week 12. The point estimate of the inter-treatment difference was 0.624 mmHg (95% CI: -0.094, 1.341). Both treatments were well-tolerated during the study, and they had similar adverse event profiles.Conclusions: PF-latanoprost/timolol combination was found to be non-inferior to the BAK-preserved formulation based on the efficacy at all times, with similar local tolerance.

scholarly journals Adjunctive therapy with brinzolamide in patients on travoprost treatment

2011 ◽  
Vol 64 (5-6) ◽  
pp. 310-314
Author(s):  
Nikola Babic ◽  
Veljko Andreic ◽  
Aleksandar Miljkovic ◽  
Vladimir Canadanovic ◽  
Sava Barisic
Keyword(s):  
Intraocular Pressure ◽  
Ocular Hypertension ◽  
Adjunctive Therapy ◽  
Open Angle Glaucoma ◽  
Combined Therapy ◽  
Previous Treatment ◽  
Open Angle ◽  
Open Label ◽  
Blurred Vision ◽  
Safety And Efficacy

Introduction. This study was aimed at evaluating the safety and efficacy of brinzolamide 1% suspension (Azopt? 1%) and travoprost 0.004% (Travatan?) combined therapy in patients with open-angle glaucoma or ocular hypertension who are in need of additional intraocular pressure lowering. Material and methods. This is a prospective, three-month, open-label, clinical study. Forty patients (80 eyes) with primary open-angle glaucoma or ocular hypertension on Travatan? treatment and with unsatis-factory results in lowering intraocular pressure were included in the study. The qualifying intraocular pressure on previous treatment with Travatan? (at least 6 weeks) was 22-36 mmHg in at least one eye at 8 a.m. intraocular pressure measurements at three eligibility visits. The patients received brinzolamide 1% twice a day in addition to travoprost 0.004% given once a day in the evening for 3 months. The follow-up examinations assessing the safety and efficacy of combined therapy of brinzolamide 1% and travoprost 0.004% were performed after 1 and 3 months. Results. Adjunctive therapy with brinzolamide resulted in statistically significant reductions in intraocular pressure from the travoprost baseline at all visits. Treatment with brinzolamide/travoprost caused statistically significant sustained reduction in intraocular pressure with the reduction of 17.39% (p<0.001) after 4 weeks and 20.08% (p<0.001) after 12 weeks. The intraocular pressure change from the baseline ranged from -3.9 mmHg after 4 weeks to -4.48 mmHg after 12 weeks. The most frequently related adverse effect was abnormal taste and blurred vision. Conclusion. Brinzolamide 1% (b.i.d.) used adjunctively with travoprost 0.004% (q.d.) lowers intraocular pressure significantly compared to travoprost alone. Both drugs were well tolerated and safe in the studied patients.

scholarly journals New Opportunities in Non-Preservative Glaucoma Therapy

2021 ◽  
Vol 18 (2) ◽  
pp. 260-265
Author(s):  
A. A. Antonov ◽  
I. V. Kozlova ◽  
A. A. Vitkov
Keyword(s):  
Intraocular Pressure ◽  
Open Angle Glaucoma ◽  
Topical Therapy ◽  
Hypotensive Effect ◽  
Current Therapy ◽  
Prospective Clinical Study ◽  
Medication Regimen ◽  
Conjunctival Hyperemia ◽  
Glaucoma Therapy ◽  
Preservative Free

Most of the medicines used for the treatment of glaucoma include a preservative in various concentrations. With long-term topical therapy, patients with glaucoma may develop dry eye syndrome (DES). The severity of symptoms depends on the number of drugs used and the presence of a preservative in them. Against the background of DES progression, compliance to glaucoma therapy may decrease, and, consequently, the effectiveness of the treatment may decrease. Currently, new non-preservative hypotensive drugs containing brimonidine, as well as a fixed combination (FC) of dorzolamide and timolol, are available on the market.Purpose: to compare assessment of the hypotensive effect and tolerability of preservative-free drugs FC Dorzolamid 20 mg/ml, Timolol 5 mg/ml (Dortmol Antiglau ECO) and Brimonidine 2 mg/ml (Brim Antiglau ECO) when switching from similar drugs containing a preservative in patients with compensated glaucoma.Patients and methods. In this prospective clinical study, 60 patients (60 eyes) with compensated primary open-angle glaucoma on combined topical therapy were examined. In group 1 (30 patients, 30 eyes), the combinations of dorzolamide / timolol or brinzolamide / timolol were switched with the non-preservative Dortmol Antiglau ECO. In group 2 (30 patients, 30 eyes), the brimonidine as part of the medication regimen were replaced with the non-preservative Brim Antiglau ECO. The level of corneal-compensated IOP was assessed before the switch in therapy and after 1 month. Subjective feelings and objective signs of the treatment’s use were monitored during examination and using a questionnaire, which was compiled to study the tolerance of therapy.Results. Switching to a preservative-free combination of dorzolamide and timolol resulted in a reduction in complaints of irritation, lacrimation, and foreign body sensation. The efficiency control did not reveal a significant change (p > 0.05) in the cornealcompensated intraocular pressure (IOPcc). When transferred to the Brim Antiglau ECO as part of the local hypotensive treatment, intraocular pressure decreased significantly (p < 0.05). The average total score characterizing drug intolerance, when evaluated by the patient, decreased by 2.4 times, by the attending physician-by 1.9 times. The degree of conjunctival hyperemia on the MacMonnies photographic scale decreased in both groups.Conclusion. Preservative-free drugs can be recommended for most patients with glaucoma as a starting treatment and as a replacement for current therapy. 

The effectiveness of descemethogoniopuncture depending on the timing of its implementation after microinvasive non-penetrating deep sclerectomy in patients with glaucoma

2021 ◽  
pp. 79-82
Author(s):  
E.L. Sorokin ◽  
◽  
N.V. Postupaeva ◽  
◽  
Keyword(s):  
Intraocular Pressure ◽  
Antihypertensive Effect ◽  
Primary Open Angle Glaucoma ◽  
Open Angle Glaucoma ◽  
Hypotensive Effect ◽  
Ultrasound Biomicroscopy ◽  
Deep Sclerectomy ◽  
Group 2 ◽  
Group 1

Purpose. Evaluation of the efficacy of descemethogoniopuncture (DGP) at various times after microinvasive non-penetrating deep sclerectomy (MNPDS) in patients with glaucoma. Material and methods. The analysis of the results of DGP in 64 eyes of patients with primary open-angle glaucoma after previously performed MNPDS. According to the timing of DGP after MNPDS, the patients were divided into 3 groups. In the 1st group BPH was performed after 1–2 months (22 eyes), the 2nd group – after 3–4 months (21 eyes), the 3rd group after 5–6 months (21 eyes). The follow-up period was 1 year. Results. The level of intraocular pressure before DGP averaged 15.1±0.6 mm Hg in group 1, 17.5±0.9 mm Hg in group 2, and group – 18.6±0.7 mm Hg. After DGP, 13.1±0.4 mm Hg, 14.6±0.7 mm Hg, 16.1±0.5 mm Hg respectively. According to ultrasound biomicroscopy, the highest and extended intrascleral cavities and tunnels, as well as a thin loose trabeculodescemet membrane (TDM), were observed in the eyes of the 1st group. With an increase in the time after MNPDS, there was a compaction of TDM, a decrease in the height and length of the intrascleral cavity and tunnels. 12 months after DGP, the most pronounced antihypertensive effect without antihypertensive therapy occurred in group 1 – 55% of cases compared with groups 2 and 3 (33% and 14% respectively). Conclusion. The greatest efficiency was shown by performing DGP within 1–2 months after MNPDS, which is associated with the minimum development of proliferative processes in the intrascleral outflow tract in the early stages after this operation. Key words: descemethogoniopuncture, microinvasive non-penetrating deep sclerectomy, intraocular pressure, hypotensive effect, glaucoma.

scholarly journals Comparison of the efficacy and safety of bimatoprost (0.03 %) and travoprost (0.004 %) in patients with primary open angle glaucoma

2013 ◽  
Vol 5 (1) ◽  
pp. 75-80 ◽  
Author(s):  
Ashish Chander ◽  
H Kapoor ◽  
S Thomas
Keyword(s):  
Intraocular Pressure ◽  
Side Effect ◽  
Primary Open Angle Glaucoma ◽  
Open Angle Glaucoma ◽  
Open Angle ◽  
Efficacy And Safety ◽  
Once Daily ◽  
The Mean ◽  
To Receive

Purpose: To compare the efficacy and safety of bimatoprost (0.03 %) and travoprost (0.004 %) in patients with primary open angle glaucoma (POAG). Subjects and methods: Patients with POAG were randomized to receive either bimatoprost or travoprost once daily. Detailed ocular examination was done and intraocular pressure (IOP) was measured at 9.00 am, 1.00 pm and 4.00 pm at the baseline and at 1, 2, 4, 6 and 12 weeks of therapy. Results: A total of 31 patients were analysed. The patients were randomly divided into two groups (Bimatoprost group = 16; Travoprost group = 15). Both the groups had a statistically significant reduction from the baseline IOP at all follow up visits at 9.00 am, 1.00 pm and 4.00 pm. The mean IOP decreased from a baseline of 25 ± 2.32 mm Hg to 15.93 ± 1.79 mm Hg after 12 weeks in the bimatoprost group (p < 0.001), and from 24.2 ± 1.60 mm Hg to 16.53 ± 1.56 mm Hg in the travoprost group (p < 0.001). A better mean reduction of IOP was obtained with bimatoprost than with travoprost at the end of the study at 12 weeks (p = 0.03). Mild ocular redness was the commonest side effect in both the groups but was not significant in either group. Conclusion: Both drugs lowered IOP effectively but bimatoprost showed a greater reduction in the mean IOP than did travoprost at 12 weeks and both are safe for ocular use. Nepal J Ophthalmol 2013; 5(9):75-80 DOI: http://dx.doi.org/10.3126/nepjoph.v5i1.7831

Efficacy and Safety of a Fixed Combination of Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution Once Daily for Open-Angle Glaucoma or Ocular Hypertension

2005 ◽  
Vol 140 (2) ◽  
pp. 242.e1-242.e11 ◽  
Author(s):  
Joel S. Schuman ◽  
Gregory J. Katz ◽  
Richard A. Lewis ◽  
J. Charles Henry ◽  
Sushanta Mallick ◽  
...  
Keyword(s):  
Ocular Hypertension ◽  
Fixed Combination ◽  
Open Angle Glaucoma ◽  
Ophthalmic Solution ◽  
Open Angle ◽  
Efficacy And Safety ◽  
Once Daily

scholarly journals Changes in Ocular Surface Characteristics after Switching from Benzalkonium Chloride-Preserved Latanoprost to Preservative-Free Tafluprost or Benzalkonium Chloride-Preserved Tafluprost

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Naoto Tokuda ◽  
Yasushi Kitaoka ◽  
Akiko Matsuzawa ◽  
Ayaka Tsukamoto ◽  
Kana Sase ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Barrier Function ◽  
Benzalkonium Chloride ◽  
Tear Film ◽  
Ophthalmic Solution ◽  
Surface Characteristics ◽  
Epithelial Barrier ◽  
Epithelial Barrier Function ◽  
Corneal Epithelial ◽  
Preservative Free

Purpose. The aim of the present study was to examine the effects of switching from Latanoprost ophthalmic solution containing a preservative to preservative-free Tafluprost ophthalmic solution or Tafluprost containing a preservative on ocular surfaces. Materials and Methods. Forty patients (40 eyes) with glaucoma (mean age: 62.0 ± 10.9 years) using Latanoprost with preservative for six months or longer were assigned either to a Tafluprost-containing-preservative group (20 eyes) or preservative-free-Tafluprost group (20 eyes). The intraocular pressure, corneal epithelial barrier function (fluorescein uptake concentration with fluorophotometer FL-500), superficial punctate keratopathy (AD classification), and tear film breakup time (TBUT) were assessed before switching and at 12 weeks after switching. Results. No significant differences in intraocular pressure were noted after switching in either group. Corneal epithelial barrier function was improved significantly after switching in both the Tafluprost-containing-preservative and the preservative-free-Tafluprost groups. There were no significant differences in AD scores after switching in the Tafluprost-containing-preservative group, but significant improvements were noted in the preservative-free-Tafluprost group. No significant differences in TBUT were noted in the Tafluprost-containing-preservative or preservative-free-Tafluprost groups after switching. Conclusion. After switching from preservative Latanoprost to Tafluprost containing-preservative or preservative-free Tafluprost, corneal epithelial barrier function was improved while the intraocular pressure reduction was retained.

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