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To assess the effect of preservative-free dorzolamide-timolol on nonvisual symptoms and intraocular pressure (IOP) in newly diagnosed and untreated patients with open-angle glaucoma or ocular hypertension.
This was a prospective, 8-week, open-label, Canadian multicenter study. All patients were treated with preservative-free dorzolamide-timolol for...
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To evaluate the additive intraocular pressure (IOP)-lowering efficacy and safety of fixed-combination brimonidine 0.2%/timolol 0.5% compared with timolol 0.5% at peak and trough effect when used as therapy adjunctive to latanoprost 0.005% in patients with glaucoma or ocular hypertension who require additional IOP lowering.
In this prospective, rand...
Citations
... Often, patients with glaucoma require lifetime topical therapy and OSD has been reported in up to 59% of patients [4,5]. Preservatives in topical antiglaucoma drops disrupt the ocular surface by a variety of mechanisms resulting in decreased tear film stability and increased evaporation [6,7]. The side effects of preserved eye drop administration include ocular hyperemia, burning, stinging, and itching that are exacerbated by an unstable tear film [7]. ...
... Preservatives disrupt the ocular surface by numerous mechanisms including cellular apoptosis and neurotoxicity causing OSD and reducing patient tolerability [6,7,19,20]. Furthermore, preservatives may cause some local corneal anesthesia masking the symptoms of OSD that may increase severity over time [17,21,22]. ...
Introduction:
To compare the tolerability and efficacy of a preservative-containing latanoprost (PCL) to a preservative-free formulation of latanoprost (PFL) in patients with open-angle glaucoma or ocular hypertension.
Methods:
A pooled analysis was performed of data from five published studies. The primary outcome was tolerability as evaluated by the severity of hyperemia. The secondary objectives were patient tolerance based on a composite ocular surface disease (OSD) score arising from ocular signs and symptoms, patient and investigator satisfaction, and a comparison of IOP-lowering efficacy.
Results:
There were three randomized controlled trials and two observational studies included in the analysis. Conjunctival hyperemia improved significantly in 25.6% (388) of patients switched to the PFL group versus 11.7% (117) of patients switched to the PCL group (p < 0.001). PFL was two times superior to PCL in reducing ocular hyperemia (odds ratio = 1.96; p < 0.001). The mean OSD composite score decreased by 32.2% in patients switched to the PFL group and 14.1% in the PCL group (p < 0.001). At 3 months, the mean IOP was similar between groups (p = 0.312).
Conclusion:
This post hoc pooled analysis confirmed the findings of the individual studies that PFL is as efficacious at reducing IOP as PCL but better tolerated. After switching to PFL, there was twice the improvement in the OSD composite score. PFL was twice as effective at reducing ocular hyperemia and other ocular signs. These findings suggest that PFL has features that may improve patient compliance, thereby potentially improving the IOP-lowering efficacy on a long-term basis.
... In contrast, most available data about the tolerability and safety of PF DTFC derives from open-label studies [30,100,101]. To date, head-to-head evidence for the tolerability profile of the unit-dose PF DTFC formulation versus preserved DTFC has been limited. ...
... The tolerability and efficacy of PF-DTFC has also been investigated by Hutnik et al [101] in an 8-week, open label, multicentre study that included 187 treatment-naïve patients with open-angle glaucoma, or ocular hypertension. The tolerability of PF DTFC was assessed using the nonvisual symptom score of the Glaucoma Symptom Scale (GSS-SYMP-6), which evaluates the following: a) burning, smarting and stinging, b) tearing, c) dryness, d) itching, e) soreness and tiredness, and f) feeling of something in the eye. ...
Introduction: Preservative-free (PF) medications represent a valuable treatment strategy in the lifelong management of glaucoma. By removing preservative toxicity, PF formulations provide tangible clinical benefits to glaucoma patients worldwide. They improve tolerability and adherence, leading to a positive impact in long-term intraocular pressure (IOP) control.
Areas covered: A critical review of the subject is provided, including selected evidence on the safety and tolerability of currently available topical PF formulations. Cumulative evidence confirms that topical PF medications are at least equally efficacious to their preserved equivalents. There is convincing short-term evidence for superior tolerability and safety of PF formulations compared to preserved medications. The long-term benefits and success of PF therapy requires further elucidation.
Expert opinion: Successful stepwise administration of medical therapy for glaucoma remains elusive. There is a greater risk for ocular toxicity and therapy failure with preserved topical glaucoma therapy. Currently available and emerging PF therapy options potentially optimize lifelong stepwise glaucoma therapy and may enhance outcome. To avert complications from preservatives leading to poor adherence, ideally, future antiglaucoma therapy should become 100% PF. There are still key aspects of PF therapy that warrant further investigation.
... Указанный эффект можно объяснить отсутствием консерванта Бензалкония Хлорида (БХ) и его токсического действия на ткани переднего отрезка глаза. Так, например, согласно данным экспериментального исследования, выполненного Kwon и соавт., повреждение эндотелия роговицы вызвано именно БХ, а не составляющими компонентами ФК Д/Т [21]. Применение ФК Д/Т, не содержащей консервантов, заметно повышает качество жизни больных глаукомой [22]. ...
Topical and systemic carbonic anhydrase inhibitors (CAIs) are widely used in the treatment of glaucoma for reducing intraocular pressure. This part of the review describes the characteristics of systemic CAIs, their side effects and the ways to overcome them, as well as contraindications. The use of CAIs during pregnancy is considered. Particular attention is paid to the antioxidant activity of CAIs and the promising development of hybrid forms based on the existing CAIs as a part of a multipurpose glaucoma treatment strategy.
... CI = Confidence Interval; SD = standard deviation. . The superscript letter a indicates a statistically significant difference compared to baseline; the superscript letter b indicates a clinically significant difference compared to baseline (difference in GSS score greater than 7, which is the amount of change used as surrogate for clinically significant improvement) [23] . Data presented as means and 95% confidence interval. ...
... Figures in parentheses indicate percentages. The superscript letter a indicates a statistically significant difference compared to baseline; the superscript b indicates a clinically significant difference compared to baseline (difference in GSS score greater than 7, which is the amount of change used as surrogate for clinically significant improvement) [23]. SYMP = symptomatic; FUNC = functional. ...
... CI = Confidence interval; SD = standard deviation; TDFC UD = preservative-free unit dose timolol/dorzolamide fixed combination; GSS = Glaucoma Symptom Scale; SYMP = symptomatic; FUNC = functional. The superscript letter a indicates a statistically significant difference compared to baseline; the superscript b indicates a clinically significant difference compared to baseline (difference in GSS score greater than 7, which is the amount of change used as surrogate for clinically significant improvement) [23]. ...
Purpose: To assess a change in visual-related quality of life (QoL) in glaucoma patients after switching from preservative-containing medical therapy to preservative-free unit dose timolol/dorzolamide fixed combination (TDFC UD). Methods: Prospective, noninterventional, multicenter 8-week study. Primary outcome was a change in visual symptoms at week 8, as assessed by the Glaucoma Symptom Scale (GSS). Results: 80 patients completed the study. There was a clinically significant increase in the scores of all GSS-related categories at week 8 when compared to baseline (GSS symptom week 8: +21.15 ± 37.9%, GSS function week 8: +10.3 ± 31.6%, both p < 0.001 vs. baseline). Comparison between patients taking only TDFC UD and patients taking TDFC UD plus concomitant medications did not detect differences in any GSS category (p > 0.50 in all comparisons). Conclusions: Switching to TDFC UD significantly improved the self-reported QoL of glaucoma patients. This can be seen even in patients who are taking concomitant ocular treatments. © 2013 S. Karger AG, Basel.
... Preservative-free Cosopt® has been developed as an alternative for those patients allergic or sensitive to the commonly used preservative benzalkonium chloride (BAK). One study has shown that this formulation lowers IOP by 38% from baseline at 8 weeks without significantly increasing ocular discomfort (as measured by the Glaucoma Symptom Scale [GSS-SYMP-6]).21 A second report demonstrated that both the preservative-free and preservative-containing formulations of dorzolamide–timolol fixed combination were equivalent in efficacy in IOP changes at peak and trough. ...
Glaucoma is a collection of diseases characterized by multifactorial progressive changes leading to visual field loss and optic neuropathy most frequently due to elevated intraocular pressure (IOP). The goal of treatment is the lowering of the IOP to prevent additional optic nerve damage. Treatment usually begins with topical pharmacological agents as monotherapy, progresses to combination therapy with agents from up to 4 different classes of IOP-lowering medications, and then proceeds to laser or incisional surgical modalities for refractory cases. The fixed combination therapy with the carbonic anhydrase inhibitor dorzolamide hydrochloride 2% and the beta blocker timolol maleate 0.5% is now available in a generic formulation for the treatment of patients who have not responded sufficiently to monotherapy with beta adrenergic blockers. In pre- and postmarketing clinical studies, the fixed combination dorzolamide-timolol has been shown to be safe and efficacious, and well tolerated by patients. The fixed combination dorzolamide-timolol is convenient for patients, reduces their dosing regimen with the goal of increasing their compliance, reduces the effects of "washout" when instilling multiple drops, and reduces the preservative burden by reducing the number of drops administered per day.
The key clinical attributes of preserved dorzolamide/timolol fixed combination (DTFC) and the emerging potential of preservative-free (PF) DTFC are reviewed with published evidence and clinical experience. The indications and role of DTFC in current glaucoma management are critically discussed. Preserved DTFC became the first intraocular pressure (IOP)-lowering fixed combination (FC) approved by the US Food and Drug Administration (FDA) and remains one of most commonly used medications worldwide. The pharmacological properties of DTFC reflect those of its two time-tested constituents, i.e., the carbonic anhydrase inhibitor dorzolamide and the non-selective beta-blocker timolol. In regulatory studies DTFC lowers IOP on average by 9 mmHg (32.7%) at peak and by 7.7 mmHg (27%) at trough. In trials DTFC shows equivalence to unfixed concomitant therapy, but in real-life practice it may prove superior owing to enhanced convenience, elimination of the washout effect from the second drop, improved tolerability, and better adherence. PF DTFC became the first PF FC approved, first in unit- dose pipettes, and more recently in a multidose format. Cumulative evidence has confirmed that PF DTFC is at least equivalent in efficacy to preserved DTFC and provides a tangible clinical benefit to patients with glaucoma suffering from ocular surface disease by improving toler- ability and adherence. Finally, we identify areas that warrant further investigation with preserved and PF DTFC.
To evaluate the safety and efficacy in intraocular pressure (IOP) reduction of increasing Cosopt dosage from twice to three times a day.
The study included patients with primary open-angle glaucoma or ocular hypertension. After a washout period, IOP was measured at baseline, after 4 weeks of treatment with Cosopt twice a day, and after another 4 weeks of treatment with Cosopt three times a day. Blood pressure, heart rate, and oxygen saturation levels were also recorded.
Twenty-nine eyes of 29 patients were included. Increasing Cosopt dosage resulted in a statistically significant (P < 0.001) additional reduction in IOP of 2.2 ± 1.58 mmHg (10.69% ± 7.49% of the baseline IOP values). There were no local or systemic adverse effects.
Treatment with Cosopt three times a day was more effective in reducing IOP than twice a day, with no effect on safety.
The purpose of this study is to compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost/timolol in a benzalkonium chloride (BAK)-free fixed combination preserved with polyquaternium-1 (TRA/TIM BAK-free), with travoprost/timolol-fixed combination preserved with BAK (TRA/TIM), in patients with open-angle glaucoma or ocular hypertension.
In this prospective randomized controlled trial, subjects with IOP of at least 22 mm Hg in one or both eyes at 0900 h, and IOP of at least 21 mm Hg in one or both eyes at 1100 h and 1600 h at two eligibility visits were randomly assigned to receive either TRA/TIM BAK-free (n=195) or TRA/TIM (n=193), dosed once daily in the morning (0900 h) for 6 weeks. IOP was assessed at 0900 h, 1100 h, and 1600 h at each scheduled visit (baseline, 2 and 6 weeks after randomization).
Mean IOP reduction across all visits and time points was 8.0 mm Hg in the TRA/TIM BAK-free group and 8.4 mm Hg in the TRA/TIM group (P=0.0943). The difference in mean IOP between groups ranged from 0.2 to 0.7 mm Hg across visits and time points, with a mean pooled difference of 0.4 mm Hg (95% CI: -0.1 to 0.8), demonstrating equivalence of the two formulations. The most common drug-related adverse event was hyperemia of the eye (ocular hyperemia and conjunctival hyperemia combined), occurring in 11.8% of the TRA/TIM BAK-free group and 13.0% of the TRA/TIM group.
Travoprost/timolol BAK-free demonstrated equivalence to travoprost/timolol preserved with BAK in efficacy. No clinically relevant differences in the safety profiles of travoprost/timolol BAK-free and travoprost/timolol preserved with BAK were identified.
