A Comparative Study on Efficacy of Intraocular Pressure Lowering of Two Fixed-Dose Antiglaucoma Drug Combination Brinzolamide-Brimonidine Versus Latanoprost-Timolol in Primary Open-Angle Glaucoma and Ocular Hypertension
Abstract and Figures
Purpose: To compare the efficacy of Brinzolamide-Brimonidine (BB) (1%+0.2%) with the gold standard Latanoprost-Timolol (LT) (0.005%+0.5%) in treating primary open-angle glaucoma (POAG) and ocular hypertension (OHT).
Methods: A 1-year prospective study, spanning from May 2022 to May 2023, conducted at a tertiary eye-care hospital. Participants, aged 40–60, with a baseline intraocular pressure (IOP) >21 mm Hg, requiring a >30% reduction, were enrolled. Group A (n = 100) received BB, and Group B (n = 100) received LT. Outcomes were assessed at 1 month (IOP difference from baseline), 3 and 6 months (mean diurnal variations).
Results: The mean age at presentation was 55.5 – 4.5 years in Group A and 54.7 – 4.2 years in Group B. At 1 month, Group A exhibited a mean IOP of 18.7 mm Hg, while Group B had 17.6 mm Hg, with no statistically significant difference (P = 0.53). No significant diurnal variation was observed in either group (P = 0.07). Target pressure was achieved in 88% of patients in Group A and slightly higher at 92% in Group B. Moreover, no serious side effects were reported, and compliance was higher in Group B (98%) compared to Group A (96%).
Conclusion: Although LT showed slightly better and sustained IOP reduction, the difference was not statistically significant. Both BB and LT demonstrated comparable outcomes for managing POAG and OHT.
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Apart from the risk of developing glaucoma there is also the risk that it is not detected and irreversible loss of vision ensues. Some studies of methods of glaucoma diagnosis have examined the results of instrument-based examinations with great if not complete reliance on objective findings in arriving at a diagnosis. The very valuable advances in glaucoma detection instrument technologies, and apparent increasing dependence on them, may have led to reduced consideration of information available from a patient history in those studies. Dependence on objective evidence of glaucomatous pathology may reduce the possibility of detecting glaucoma suspects or patients at risk for becoming glaucoma suspects. A valid positive family history of glaucoma is very valuable information. However, negative family histories can often be unreliable due to large numbers of glaucoma cases being undiagnosed. No evidence of family history is appropriate rather than no family history. In addition the unreliability of a negative family history is increased when patients with glaucoma fail to inform their family members. A finding of no family history can only be stated as no known family history. In examining the potential diagnostic contribution from a patient history, this review considers, age, frailty, race, type and degree of refractive error, systemic hyper- and hypotension, vasospasm, migraine, pigmentary dispersion syndrome, pseudoexfoliation syndrome, obstructive sleep apnea syndrome, diabetes, medication interactions and side effects, the degree of exposure to intraocular and intracranial pressure elevations and fluctuations, smoking, and symptoms in addition to genetics and family history of the disease.
Purpose
To analyze patterns of use of adjunctive therapies among new initiators of topical prostaglandin analogs (PGAs) in a managed care population.
Methods
The study cohort included patients in a claims database who initiated PGA therapy between June 2007 and April 2011. Patients who had one or more adjunctive therapy prescriptions during 24 months of follow-up were included. Patterns of adjunctive therapy use were identified and compared between patients who had one or two fills of the initial adjunctive therapy and those who had three or more.
Results
There were 16,486 eligible beneficiaries. Of these, 5,933 (36%) had one or more adjunctive therapies within 24 months from the start of the PGA, 82% of whom started adjunctive therapy within 12 months. About 28% of patients started adjunctive therapy with a fixed-combination product; 45% of these patients started within the first 30 days. Overall, a large number of patients (42%) required adjunctive therapy within 30 days. Twenty-five percent of patients had only one or two prescriptions of their initial adjunctive therapy; of these patients, 74% discontinued adjunctive therapy altogether.
Conclusion
Approximately 30% of patients starting glaucoma therapy will require adjunctive therapy within 1 year, and many receive a fixed-combination product as initial adjunctive therapy shortly after starting glaucoma therapy. This suggests a prescribing trend toward earlier, more aggressive drug therapy to control pressure and minimize disease progression. We found that compliance with adjunctive therapy continues to be a problem for patients, which could be attributed to a number of treatment burden and economic factors.
PurposeTo describe pooled efficacy and safety data from two phase 3 studies comparing brinzolamide 1%/brimonidine 0.2% fixed combination (BBFC) with its component medications, brinzolamide and brimonidine, in patients with open-angle glaucoma or ocular hypertension.Methods
Data were pooled from two nearly identical clinical trials comparing BBFC with its component medications, each given three times daily. The 3-month efficacy outcome was mean intraocular pressure (IOP) at 0800, 1000, 1500, and 1700 hours. Safety outcomes included adverse events (AEs), best-corrected visual acuity, examination of ocular structures, pachymetry, perimetry, and vital signs.ResultsA total of 1350 patients were enrolled and included in this analysis (BBFC, n=437; brinzolamide, n=458; brimonidine, n=455). Baseline mean IOP levels were similar among the three treatment groups. At 3 months, mean IOP of the BBFC group was significantly lower than that of either monotherapy group (P<0.0001) at all the four time points. A total of 272 patients (20.1%) experienced at least one treatment-related AE (BBFC, 24.6%; brinzolamide, 18.7%; brimonidine, 17.4%), the majority of which were ocular AEs. One serious AE, moderate intensity chest pain, was considered related to brinzolamide treatment and resulted in study discontinuation.Conclusions
This analysis strengthens the conclusions drawn from the two individual phase 3 studies showing that, in patients with open-angle glaucoma or ocular hypertension, BBFC had significantly superior IOP-lowering activity compared with either brinzolamide or brimonidine alone and a safety profile consistent with that of its individual components.Eye advance online publication, 3 May 2013; doi:10.1038/eye.2013.83.
Purpose:
To study resident compliance with the American Academy of Ophthalmology (AAO) Preferred Practice Patterns (PPPs) for primary open-angle glaucoma suspect (POAGS) in a resident ophthalmology clinic.
Patients and methods:
Two hundred charts were selected for analysis of adult patients with the International Classification of Diseases diagnosis code for POAGS during their initial visit between November 2, 2010 and May 6, 2014 at the Kresge Eye Institute resident clinic. Electronic medical records of clinic visits for POAGS patients were evaluated for documentation and compliance with 17 elements of AAO PPPs.
Results:
The overall mean compliance was 73.8% for all charts (n=200), 74.4% for first-year residents (n=53), 74.5% for second-year residents (n=38), and 73.3% for third-year residents (n=109). Documentation rates were high (>90%) for 9 elements, which included most elements of physical examination and history. Documentation of ocular history, central corneal thickness, gonioscopy, optic nerve head and retinal nerve fiber layer analysis, and visual field ranged from 40% to 80%. Documentation was lowest for patient education elements which ranged from 0% to 10%. Compliance was not significantly different (P>0.05) between residents or between different resident years for any element.
Conclusions:
Residents' compliance was high for most elements of the PPPs for POAGS. We identified elements with poor compliance especially regarding patient education. Adherence to AAO PPPs can be a helpful method of assessing resident performance.
To examine resident adherence to preferred practice pattern (PPP) guidelines set up by the American Academy of Ophthalmology for follow-up care of primary open-angle glaucoma (POAG) patients.
Retrospective chart review.
One hundred three charts were selected for analysis from all patients with an International Classification of Diseases, Ninth Revision, code of open-angle glaucoma or its related entities who underwent a follow-up evaluation between July 2, 2003, and December 15, 2004, at the resident ophthalmology clinic in the Durham Veteran Affairs Medical Center.
Follow-up visits of POAG patients were evaluated for documentation of 19 elements in accordance to PPP guidelines.
Compliance rates for the 19 elements of PPP guidelines first were averaged in all charts, and then were averaged per resident and were compared among 8 residents between their first and second years of residency.
The overall mean compliance rate for all 19 elements was 82.6% for all charts (n = 103), 78.8% for first-year residents, and 81.7% for second-year residents. The increase from first to second year of residency was not significant (P > 0.05). Documentation rates were high (>90%) for 14 elements, including all components of the physical examination and follow-up as well as most components of the examination history and management plan. Residents documented adjusting target intraocular pressure downward, local or systemic problems with medications, and impact of visual function on daily living approximately 50% to 80% of the time. Documentation rates for components of patient education were the lowest, between 5% and 16% in all charts.
Residents' compliance with PPP guidelines for a POAG follow-up visit was very high for most elements, but documentation rates for components of patient education were poor. Adherence rates to PPP guidelines can be used as a tool to evaluate and improve resident performance during training. However, further studies are needed to establish the advantages of using PPP guidelines for resident education and to determine if such assessments can lead to improved patient care.
The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Purpose:
To investigate factors associated with bilateral glaucoma blindness, particularly factors available at the time of diagnosis.
Methods:
Retrospective chart review of all patients with primary open-angle glaucoma (POAG) or pseudoexfoliative glaucoma (PEXG) followed at the Department of Ophthalmology or Low Vision Center of Skåne University Hospital, Malmö, Sweden, who died between January 2006 and June 2010. Disease stage at diagnosis was defined by a simplified version of Mills' glaucoma staging system using perimetric mean deviation (MD) to define six stages of severity. Blindness was defined according to WHO criteria. We used logistic regression analysis to examine the association between risk factors and glaucoma blindness.
Results:
Four hundred and 23 patients were included; 60% POAG and 40% PEXG. Sixty-four patients (15%) became blind from glaucoma. Blind patients had significantly longer mean duration with diagnosed disease than patients who did not go blind (14.8 years ± 5.8 versus 10.6 years ± 6.5, p < 0.001). The risk of blindness increased with higher intraocular pressure (IOP) (OR 1.08, 95% CI 1.03-1.13) and with each stage of more advanced field loss at time of diagnosis (OR 1.80 95% CI 1.34-2.41). Older age at death was also associated with an increased risk of blindness (OR 1.09 95% CI 1.03-1.14), while age at diagnosis was unimportant. PEXG was not an independent risk factor for blindness.
Conclusions:
Higher IOP and worse visual field status at baseline were important risk factors, as was older age at death.
PurposeTo determine the impact of coadminstration of systemic β-blockers on the ocular hypotensive efficacy and safety of topical timolol, a nonselective β-blocker, and that of brimonidine, an α2-selective adrenergic agonist, in patients with glaucoma or ocular hypertension.
Importance This study evaluates the contribution of the individual components of an investigational non–β-antagonist fixed combination of brinzolamide, 1%, and brimonidine, 0.2%. This study and its sister study provide the first randomized data showing the intraocular pressure (IOP)-lowering activity and the toxicity profile of this novel topical antihypertensive fixed combination.
Objective To compare IOP-lowering efficacy of fixed-combination brinzolamide, 1%, and brimonidine, 0.2%, with that of its components in patients with open-angle glaucoma or ocular hypertension.
Design In this phase 3, double-masked, parallel-group, multicenter study, eligible patients were randomized 1:1:1 to treatment with fixed-combination brinzolamide, 1%, and brimonidine, 0.2%; brinzolamide, 1%; or brimonidine, 0.2%, 3 times daily for 3 months.
Setting Sixty-six academic and private practice study sites throughout the United States.
Participants A total of 660 adults with a clinical diagnosis of open-angle glaucoma or ocular hypertension from a referred sample were enrolled. Thirty-four patients discontinued participation due to treatment-related nonserious adverse events.
Intervention Topical administration of study medication (fixed-combination brinzolamide, 1%, and brimonidine, 0.2%; brinzolamide, 1%; or brimonidine, 0.2%) 1 drop 3 times daily for 3 months.
Main Outcomes and Measures Mean IOP at the 3-month visit at all time points (8 AM, 10 AM, 3 PM, and 5 PM).
Results A total of 660 patients were enrolled. Baseline mean IOP values were similar among treatment groups at all 4 time points. At 3 months, the mean IOP of the brinzolamide-brimonidine group (16.3-19.8 mm Hg) was significantly lower than that of either the brinzolamide group (19.3-20.9 mm Hg; P ≤ .002) or the brimonidine group (17.9-22.5 mm Hg; P < .001) across all time points. One of 10 serious adverse events (chest pain, brinzolamide group) was judged as treatment related. A total of 129 patients experienced at least 1 treatment-related adverse effect (brinzolamide-brimonidine, 22.9%; brinzolamide, 18.6%; and brimonidine, 17.3%; P = .31), most of which were ocular.
Conclusions and Relevance This registrational study provides evidence that the fixed combination of brinzolamide, 1%, and brimonidine, 0.2%, can safely and effectively lower IOP in patients with open-angle glaucoma or ocular hypertension, showing significantly superior IOP-lowering activity compared with either brinzolamide or brimonidine monotherapy while providing a safety profile consistent with that of its individual components.
Trial Registration clinicaltrials.gov Identifier: NCT01297517
Purpose:
This study compared the intraocular pressure (IOP)-lowering efficacy of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) with that of its component medications, brinzolamide and brimonidine, in patients with open-angle glaucoma or ocular hypertension.
Patients and methods:
In this phase 3, multicenter, double-masked, parallel-group, 3-month study with a 3-month safety extension, eligible patients were randomized 1:1:1 to treatment with BBFC, brinzolamide, or brimonidine thrice daily after a washout period, during which any IOP-lowering medications were discontinued. The primary objectives of this study were to determine whether the IOP-lowering efficacy of BBFC was superior to that of brinzolamide alone and, separately, of brimonidine alone. IOP was assessed at 8:00 AM, 10:00 AM, 3:00 PM, and 5:00 PM at 2 weeks, 6 weeks, and 3 months after study drug initiation.
Results:
A total of 690 patients were enrolled in the study, and 615 completed the 3-month visit. Baseline mean IOP levels were similar among the 3 treatment groups at each of the 4 time points assessed. At the 3-month primary endpoint, mean IOP of the BBFC group was significantly lower than that of either the brinzolamide group or the brimonidine group (P≤0.005) across all time points. At the 2- and 6-week supportive endpoints, mean IOP of the BBFC group was significantly lower at all time points than the mean IOP of either the brinzolamide group (P≤0.01) or the brimonidine group (P<0.0001). A total of 143 patients experienced at least 1 treatment-related adverse event (AE; BBFC group, n=58, 26.2%; brinzolamide group, n=44, 18.8%; brimonidine group, n=41, 17.4%), the majority of which were ocular AEs.
Conclusions:
This study demonstrated that BBFC has significantly superior IOP-lowering activity compared with either brinzolamide 1% or brimonidine 0.2% in patients with open-angle glaucoma or ocular hypertension while providing a safety profile which is consistent with that of the individual components.