scholarly journals Comparative efficacy study of brimonidine tartrate 0.15% and timolol maleate 0.5% ophthalmic solution (benzalkonium chloride free) versus Brimolol® (with benzalkonium chloride) following single ocular instillation in New Zealand white rabbits

2020 ◽  
Vol 9 (7) ◽  
pp. 1050
Author(s):  
Amit Thavkar ◽  
Sateesh Kumar Chauhan ◽  
Subhas Bhowmick ◽  
Vinod Burade
Keyword(s):  
Intraocular Pressure ◽  
New Zealand ◽  
Repeated Measures ◽  
Benzalkonium Chloride ◽  
Ophthalmic Solution ◽  
Eye Drops ◽  
Timolol Maleate ◽  
Repeated Measures Analysis ◽  
Brimonidine Tartrate ◽  
Ophthalmic Solutions

Background: Benzalkonium chloride (BKC) is the most used preservative in topical eye drops but it causes effects such as dry eye and trabecular meshwork degeneration. Polyhexamethylene biguanide (PHMB) is a polymeric biguanide is a less harmful preservative used in ophthalmic solutions. The objective of this study to com-pare the efficacy of PHMB preserved versus BKC preserved ophthalmic solutions containing brimonidine tartrate and timolol maleate on intraocular pressure (IOP) following single ocular instillation in New Zealand white (NZW) rabbits.Methods: This study was conducted on 12 normotensive male NZW rabbits (2.9-3.6 kg) between 6-9 months of age. Animals received single ocular instillation of 35 µl ophthalmic solution containing brimonidine tartrate 0.15 %w/v and timolol maleate 0.5% w/v with PHMB as preservative (n=6, test) or BKC as preservative (n=6, reference) as per the randomization. Intraocular pressure (IOP) was measured before and 2, 4, 6, 8 and 24 hours after instillation using a pneumatonometer. Percentage change in IOP from pre-instillation values were calculated. Changes in IOP were analysed using the repeated-measures analysis of variance followed by Bonferroni post-test.Results: Single ocular instillation of PHMB and BKC formulations show significant IOP reduction up to 6 hours as compared with baseline (p<0.05). Reduction in IOP was 35.8% and 32.0% at 2 hours with PHMB and BKC formulations respectively. No differences were observed between the test and reference groups for change in IOP from baseline.Conclusions: PHMB preserved brimonidine tartrate 0.15% w/v and timolol maleate 0.5% w/v ophthalmic solution was comparable to BKC preserved solution in normotensive NZW rabbits.

scholarly journals The Efficacy and Safety of Preservative-containing and Preservative-free Brimonidine-Timolol Fixed Combination in Normal Tension Glaucoma

2021 ◽  
Vol 62 (10) ◽  
pp. 1407-1414
Author(s):  
Bo Kyung Kim ◽  
Si Nae Kim ◽  
Joon Mo Kim
Keyword(s):  
Intraocular Pressure ◽  
Adverse Effects ◽  
Fixed Combination ◽  
Normal Tension Glaucoma ◽  
Eye Drops ◽  
Efficacy And Safety ◽  
Timolol Maleate ◽  
Combination Drug ◽  
Brimonidine Tartrate ◽  
Preservative Free

Purpose: To analyze the efficacy and safety of preservative-containing and preservative-free 0.2% brimonidine tartrate and 0.5% timolol maleate fixed combination drug in normal tension glaucoma.Methods: Fifty-one patients (84 eyes) who were diagnosed with normal tension glaucoma and with preservative-containing or preservative-free brimonidine-timolol fixed combinations alone were analyzed retrospectively from January 2017 to February 2020. Intraocular pressure (IOP) was measured four times a day (9 a.m., 11 a.m., 2 p.m., and 4 p.m.) before and at 6 months after applying eye drops. We analyzed and compared the effect of lowering IOP and the occurrence of intra or extra-ocular adverse effects.Results: A significant mean IOP reduction was shown in both groups: -1.95 ± 2.50 mmHg (-12.26 ± 15.87%) in the preservative-containing group and -1.60 ± 2.06 mmHg (-10.54 ± 13.94%) in the preservative-free group at 6 months after eyedrop instillation. The IOP was lowest in both groups at 11 a.m. There were no significant differences between the two groups in lowering IOP. Serious adverse effects causing discontinuation of the eye drops were not observed.Conclusions: Both preservative-containing and preservative-free brimonidine-timolol fixed combinations are effective in lowering IOP in normal tension glaucoma patients and are considered to be effective as eye drops without serious adverse effects.

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 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.

scholarly journals Selective Laser Trabeculoplasty Versus Brimonidine Tartrate 0.2%/Timolol Maleate 0.5% As Adjunct Therapy in Primary Open Angle Glaucoma: A Randomized Prospective Trial

2020 ◽  
Author(s):  
Ian McWherter ◽  
Meredith Lanham ◽  
Lee Peplinski ◽  
Nikolaos Zagorianos ◽  
Andrew Steele ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Primary Open Angle Glaucoma ◽  
Open Angle Glaucoma ◽  
Complication Rates ◽  
Open Angle ◽  
Selective Laser Trabeculoplasty ◽  
Timolol Maleate ◽  
Adjunct Therapy ◽  
Laser Trabeculoplasty ◽  
Brimonidine Tartrate

Abstract Purpose: To compare the intraocular pressure lowering efficacy of selective laser trabeculoplasty to brimonidine tartrate 0.2%/timolol maleate 0.5% in patients with uncontrolled primary open-angle glaucoma on a prostaglandin analog alone. A secondary outcome was to evaluate the complication rates of selective laser trabeculoplasty.Patients and Methods: Twenty-three patients were randomized to two treatment groups within this prospective, observer-masked single site, all optometrist, pilot study. Group 1 (N=12) received 360 degrees of selective laser trabeculoplasty as additional treatment while Group 2 (N=11) was started on FCBT. Outcomes of both groups were measured at eight weeks.Results: Both treatment regimens were found to be statistically significant in lowering IOP when used as adjunct therapy. The average IOP reduction for Group 1 and Group 2 was 28.4% (SD = .17) and 28.2% (SD = .12) respectively. The incidence of an intraocular pressure spike following SLT in this patient population was found to be 8.3%. No major complications were observed in this study.Conclusion: Selective laser trabeculoplasty and brimonidine tartrate 0.2%/timolol maleate 0.5% were shown to be equivalent in lowering intraocular pressure in uncontrolled primary open angle glaucoma patients when used as adjunct therapy for patients on a prostaglandin analog. Additionally, this is the first prospective study of optometrists performing selective laser trabeculoplasty. Although this study had a small sample size, the results appeared to show that efficacy and complication rates were comparable to previously published data; however, these results need to be confirmed with a larger multi-centered trial.Trial Registration: ISRCTN Study ID ISRCTN30070325, retrospectively registered 12/14/2018. http://www.isrctn.com/ISRCTN30070325.

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 The effects of premedication with methadone on intraocular pressure in dogs and cats

2021 ◽  
Author(s):  
Esmeralda Delgado ◽  
André Delgado da Silva ◽  
Mariana Pinto Nunes
Keyword(s):  
Intraocular Pressure ◽  
Repeated Measures ◽  
Blink Reflex ◽  
Post Treatment ◽  
Respiratory Pattern ◽  
Ophthalmological Examination ◽  
Safe Alternative ◽  
Clinically Normal ◽  
Repeated Measures Analysis ◽  
Healthy Dogs

Abstract Background: The effects of premedication agents on the ocular physiology should be thoroughly understood by the ophthalmic surgeon so that intraocular pressure (IOP) values are kept stable. The purpose of this study was to determine the effects of methadone as a solo-agent of anaesthetic premedication on IOP in healthy dogs and cats.The study group included 60 clinically normal patients, 40 dogs and 20 cats. Ophthalmological examination, including baseline IOP (T0) of the subjects, was performed before methadone administration at a dosage of 0.2 mg kg-1. IOP variations were registered fifteen (T15) and thirty (T30) minutes later. IOP values were compared at each specific timepoint (T0, T15 and T30) using a repeated-measures analysis of variance (ANOVA) and differences were considered significant when P < 0.05. Results: The sedative effect of methadone did not affect the ocular globe or nictitating membrane position nor the menace response, dazzle reflex, corneal blink reflex or palpebral reflexes in any case. None of the animals studied presented with the secondary effects associated with opioids such as salivation, nausea, vomit, defecation, dysphoria or a clear modification of the respiratory pattern, The mean ± SD baseline (T0) and post-treatment (T15, T30) IOP values were, respectively, 16,8 ± 3,84 mmHg, 17,6 ± 3,01 mmHg and 16,1 ± 3,28 mmHg for dogs and 17,1 ± 3,31 mmHg, 16,6 ± 3,40 mmHg and 16,61 ± 2,81 for cats. There were no statistically significant differences between baseline and post-treatment values in dogs (p=0,107) or cats (p=0.077). Conclusions: The administration of methadone as a solo-agent of anaesthetic premedication at a dosage of 0.2 mg kg-1 did not cause significant changes on IOP values in dogs or cats. Methadone presented as a safe alternative for sedation, anaesthetic premedication or analgesia in ophthalmological patients since it did not interfere with IOP regulation.

scholarly journals Effects of fentanyl on intraocular pressure and pupil size in medetomidine-methadone premedicated dogs: a pilot study

2020 ◽  
Vol 7 (1) ◽  
pp. e000391
Author(s):  
Maria Isabel Gomez-Martinez ◽  
Oscar Varela-Lopez ◽  
Jose Luis Fontalba-Navas ◽  
Antonio González-Cantalapiedra
Keyword(s):  
Intraocular Pressure ◽  
Pilot Study ◽  
Intravenous Injection ◽  
Repeated Measures ◽  
Pupil Size ◽  
Saline Solution ◽  
Control Group ◽  
Time Points ◽  
Repeated Measures Analysis ◽  
Fentanyl Group

BackgroundThis is a pilot study to evaluate the effects of fentanyl on intraocular pressure (IOP) and pupil size (PS) in dogs premedicated with medetomidine and methadone.MethodsSixteen dogs with a median (first quartile–third quartile) age of 3.5 (1.25–6) years and a mean (sd) weight of 18.6 (9.2) kg were included. Baseline readings of IOP and PS were recorded before all dogs were premedicated intramuscularly with medetomidine (10 µg/kg) and methadone (0.5 mg/kg). Both measurements were repeated 15 and 30 minutes later. Following this, the dogs were randomly assigned into two groups. The fentanyl group received intravenous fentanyl (10 µg/kg), while the control group received the same volume of saline solution intravenously. IOP and PS measurements were measured and recorded in both groups at one, five and ten minutes after intravenous injection. Data were analysed with one-way and two-way repeated-measures analysis of variance or their non-parametric equivalents.ResultsPS was significantly decreased 15 and 30 minutes following intramuscular premedication and IOP was significantly increased in the fentanyl group at all time points following intravenous administration.ConclusionsMedetomidine, methadone and fentanyl combinations are not recommended for use in patients where an increase in IOP or decrease in PS is undesirable.

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