Topical Bimatoprost Insert for Primary Open-Angle Glaucoma and Ocular Hypertension Treatment - A Phase II Controlled Study

2021 ◽  
Vol 18 ◽  
Author(s):  
Francine Rubião ◽  
Alan Cezar Faria Araújo ◽  
João Bernardo Sancio ◽  
Bárbara Silva Nogueira ◽  
Juçara Ribeiro Franca ◽  
...  

Background: The most common treatment for primary open-angle glaucoma (POAG) is the daily use of eye drops. Sustained-release drug delivery systems have been developed to improve patient adherence by achieving prolonged therapeutic drug concentrations in ocular target tissues while limiting systemic exposure. The purpose of this study is to compare the efficacy and safety of bimatoprost inserts with bimatoprost eye drops in patients with POAG and ocular hypertension (OH). Methods: We include OH and POAG patients aged between 40 and 75 years-old. Both OH and POAG patients had intraocular pressure (IOP) greater than 21 and ≤30 mmHg at 9:00 am without glaucoma medication and normal biomicroscopy. Five normal patients with IOP≤14 mmHg constitute the control group. A chitosan-based insert of bimatoprost was placed at the upper conjunctival fornix of the right eye. In the left eye, patients used one drop of LumiganTM daily at 10:00 pm. For statistical analysis, we used a two-way analysis of variance (ANOVA), Student t-test, and paired t-test. Results: Sixteen POAG and 13 OH patients with a mean age of 61 years were assessed. In both eyes, IOP reduction was similar during three weeks of follow-up (19.5±2.2 mmHg and 16.9±3.1 mmHg), insert, and eye drop, respectively; P=0.165). The percentage of IOP reduction in the third week was 30% for insert and 35% for eye drops (P=0.165). No intolerance or discomfort with the insert was reported. Among the research participants, 58% preferred the use of the insert while 25% preferred eye drops, and 17% reported no preference. Conclusions: Bimatoprost-loaded inserts showed similar efficacy to daily bimatoprost eye drops during three weeks of follow up, without major side effects. This might suggest a possible change in the daily therapeutic regimen for the treatment of POAG and OH.

2021 ◽  
Vol 29 (02) ◽  
pp. 93-97
Author(s):  
Falak Naz ◽  
Muhammad Saleh Faisal ◽  
Waheed Iqbal ◽  
Momina Naz ◽  
Muhammad sajid Khan ◽  
...  

ABSTRACT Objective: To compare levobunolol and travoprost for lowering the intra-ocular pressure (IOP) in patients of ocular hypertension and primary open-angle glaucoma. Materials and Methods: A Quasi experimental study was conducted in the ophthalmology department of Khyber Teaching Hospital, Peshawar. 120 patients of both genders and age between 18-80 years with ocular hypertension or primary open angle glaucoma requiring single pressure lowering drug were enrolled in the study. Subjects were divided into two groups (60 in each). One group was treated with travoprost eye drops (0.004%, OD) while other group with levobunolol eye drops (0.5%, OD). After initial screening visit where demographic data and baseline IOP was recorded on structured proforma, three follow-up visits were arranged each at 02 weeks interval. At each follow-up visit, IOP was recorded by standard protocols to evaluate and compare the ocular hypotensive efficacy of study drugs by calculating mean IOP change from the baseline. Only patients with no missing IOP measurements for all visits were considered eligible for the efficacy evaluation. Results: A total of 120 patients were observed having age range from 18 years and above with mean age 52.16 ± 9.56 and predominance of male gender. Upon comparative analysis, no significant statistical difference (p value >0.05) was observed in the ocular hypotensive efficacy of levobunolol and travoprost measured at each follow-up visit, indicating both the drugs equally effective. Moreover, age groups did not reveal any significant statistical impact on the treatment outcome of patients treated with either study drug. Conclusion: Though both the drugs are equally effective, levobunolol is better option than travoprost for the treatment of glaucoma because of its fast onset of action, cost effectiveness and easy availability.


2012 ◽  
Vol 46 (4) ◽  
pp. 172-176
Author(s):  
Sukhsagar Ratol ◽  
Rani Walia ◽  
Mridu Chaudhry

ABSTRACT Background Glaucoma is a leading cause of irreversible blindness. The fundamental problem in medical management of glaucoma is of patient compliance. An ideal drug or a drug combination is needed to slow the progression of this majorly symptomless disease. Aim To compare the efficacy and tolerability of the fixed combination latanoprost and timolol instilled once daily in the evening vs fixed combination of dorzolamide and timolol instilled twice daily in primary open angle glaucoma or ocular hypertension. Materials and methods A 12-week, randomized, open, parallel group study including 50 patients with primary open angle glaucoma or ocular hypertension was conducted at a tertiary care hospital. Patients were randomized to group 1, (fixed combination (FC) latanoprost and timolol eye drops, once daily in evening) and group 2, (FC dorzolamide and timolol eye drops, twice daily). At baseline, 2, 4 and 12 weeks, IOP was recorded at 9 AM and 12 noon. The difference in IOP reduction in two treatment groups from baseline to 12 weeks was the main outcome measure. Results Mean diurnal IOP was similar at baseline for both groups. Mean reduction in IOP from baseline to 12 weeks was 9.92 mm Hg (p = 0.001) in group 1 and 9.22 (p = 0.001) in group 2. The reduction in IOP in both groups 1 and 2 was statistically significant at all time intervals. There was a statistically significant advantage for group 1 at 12 weeks for both time readings (p = 0.013 and 0.002 respectively) as compared to group 2. Conclusion The fixed combination of latanoprost and timolol was more effective than that of dorzolamide and timolol in reducing mean diurnal IOP and both treatments were well tolerated. To confirm further such studies are required. How to cite this article Ratol S, Walia R, Chaudhry M. A Comparative Analysis of the Efficacy and Safety of fixed Combinations of Latanoprost/Timolol vs Dorzolamide/Timolol in Primary Open Angle Glaucoma or Ocular Hypertension. J Postgrad Med Edu Res 2012;46(4):172-176.


Ophthalmology ◽  
1993 ◽  
Vol 100 (11) ◽  
pp. 1614-1618 ◽  
Author(s):  
Anthony P. Moriarty ◽  
J. Dominic A. McHugh ◽  
Timothy J. ffytche ◽  
John Marshall ◽  
A.M. Peter Hamilton

2013 ◽  
Vol 141 (7-8) ◽  
pp. 441-446 ◽  
Author(s):  
Nikola Babic ◽  
Veljko Andreic ◽  
Aleksandar Miljkovic ◽  
Desanka Grkovic ◽  
Predrag Jovanovic

Introduction. Combining two medications in one bottle may improve compliance by reducing the time required to administer drops and the frequency of the total number of medication bottles. Objective. To compare the efficacy of reduced intraocular pressure (IOP) and safety of fixed combination travoprost 0.004%/timolol 0.5% vs. fixed combination dorzolamide 2%/timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension. Methods. Prospective randomized clinical study included 60 patients divided into 2 groups. Follow-up was done at day 14 and 45 and month 3. IOP measurements were taken at each follow-up examination at 8 am, 10 am and 4 pm. Results. Both fixed combinations reduced IOP significantly compared to initial values at all follow-ups (p<0.001). Mean pooled IOP at all visits and time points was slightly lower in the travoprost/timolol group compared with the dorzolamide/timolol group (16.13 mmHg vs. 16.15 mmHg). Mean IOP reduction from baseline ranged from -7.46 mmHg to -9.92 mmHg in the travoprost/timolol group and from -6.93 mmHg to -8.93 mmHg for the dorzolamide/timolol group. Mean (?standard error of the mean) reduction in diurnal IOP from baseline to 3rd month was 8.96?2.79 in the travoprost/timolol group versus 8.07?2.91 in patients receiving dorzolamide/timolol fixed combination (p=0.196). The most frequent treatment-related adverse events were conjunctival hyperemia in the travoprost/timolol group, and dry eye and foreign body sensation in the dorzolamide/timolol group. Conclusion. Travoprost/timolol fixed combination was slightly more effective than dorzolamide/timolol fixed combination in reducing mean diurnal IOP. Travoprost/timolol group resulted in an IOP reduction for up to 1.07 mmHg higher than dorzolamide/timolol group. Both fixed combinations were well tolerated and safe.


2020 ◽  
Author(s):  
Marcelo Ayala

Abstract Background: The present study aimed to compare visual field progression in new-diagnosed exfoliation versus open-angle glaucoma patients. Methods: Retrospective study. The study included patients with new-diagnosed primary open-angle and exfoliation glaucoma. All patients were followed for three years with reliable visual fields. At least five reliable fields were needed for inclusion. Exfoliation and open-angle glaucoma were defined based on the European Glaucoma Society guidelines. Visual field evaluation was performed using the software threshold 24-2 of the Humphrey Field Analysis. Outcomes: Visual field progression. For visual field progression, three different strategies were used: mean deviation (MD), visual field index (VFI), and the guided progression analysis (GPA). Results: The study included 128 subjects, of the 54 in the open-angle and 74 in the exfoliation glaucoma group. The MD difference values were higher in the exfoliation (-3.17 dB) than in the primary open-angle (-1.25 dB) glaucoma group in the three-year follow-up period. The difference between groups was significant (t-test, p=<0.001). The difference in VFI was calculated for the three years follow-up period. The difference was higher in the exfoliation (-7.65%) than in the primary open (-1.90%) glaucoma group (t-test, p=<0.001). The GPA showed progression in 58% of cases in exfoliation, and 13% in primary open glaucoma group (Chi-square, p=<0.001). Conclusion: The present study found a more frequent and faster visual field progression in exfoliation than in primary open-angle glaucoma patients. New-diagnosed exfoliation glaucoma patients must be controlled and treated more strictly than primary open-angle glaucoma patients to avoid visual field deterioration.


2021 ◽  
Vol 14 (10) ◽  
pp. 1539-1547
Author(s):  
Joon Mo Kim ◽  
◽  
Ji Woong Lee ◽  
Haksu Kyung ◽  
Seungsoo Rho ◽  
...  

AIM: To evaluate the therapeutic efficacy, safety and tolerability of newly developed preservative-free (PF) latanoprost generic [TJO-002] and compare it with benzalkonium chloride (BAK)-preserved latanoprost [Xalatan®] in patients with primary open angle glaucoma (POAG) and ocular hypertension (OHT). METHODS: Included patients were aged ≥19y with POAG/OHT. After a washout period, patients with IOP 21-35 mm Hg at 9 a.m. were enrolled. After a full ophthalmic and glaucoma examination, 144 patients with POAG and OHT participated in this study. Subjects were randomly assigned either PF latanoprost (74 eyes) or BAK-preserved latanoprost (70 eyes). All subjects were examined at 4, 8, and 12wk after first administration. At each follow-up visit, IOP was measured at 9 a.m. and 5 p.m. and compliance was assessed. Throughout the study, all adverse events were recorded and monitored by the masked investigators who measured IOP. RESULTS: Both groups showed a statistically significant decrease of average diurnal IOP at 12wk compared to baseline (-7.21±3.10 mm Hg in the PF latanoprost group and -7.02±3.17 mm Hg in the BAK latanoprost group, both P<0.0001). There was no statistically significant diurnal IOP variation between the groups. In terms of tolerability, pruritus, burning/stinging, and sticky eye sensation, severity was significantly lower in the PF latanoprost group than in the BAK latanoprost group (P<0.05). CONCLUSION: PF latanoprost has at least similar efficacy in terms of IOP reduction and better tolerability compared with BAK latanoprost.


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