PSS4 Longer Term Patient Benefits of Polyquad® Preservative Instead of Benzalkonium Chloride in Prostaglandin Eye Drops: A Microsimulation Model in Ocular Hypertension and Open-Angle Glaucoma

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.

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Efficacy and safety of tafluprost 0.0015% versus latanoprost 0.005% eye drops in open-angle glaucoma and ocular hypertension: 24-month results of a randomized, double-masked phase III study

Acta Ophthalmologica ◽

10.1111/j.1755-3768.2010.01862.x ◽

2010 ◽

Vol 88 (1) ◽

pp. 12-19 ◽

Cited By ~ 65

Author(s):

Hannu Uusitalo ◽

Lutz E Pillunat ◽

Auli Ropo ◽

Keyword(s):

Ocular Hypertension ◽

Open Angle Glaucoma ◽

Phase Iii ◽

Eye Drops ◽

Open Angle ◽

Efficacy And Safety ◽

Phase Iii Study

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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

Journal of Postgraduate Medicine Education and Research ◽

10.5005/jp-journals-10028-1039 ◽

2012 ◽

Vol 46 (4) ◽

pp. 172-176

Author(s):

Sukhsagar Ratol ◽

Rani Walia ◽

Mridu Chaudhry

Keyword(s):

Ocular Hypertension ◽

Primary Open Angle Glaucoma ◽

Fixed Combination ◽

Open Angle Glaucoma ◽

Eye Drops ◽

Open Angle ◽

Once Daily ◽

Group 2 ◽

Diurnal Iop ◽

Group 1

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.

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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

Medical hypothesis discovery and innovation in ophthalmology ◽

10.51329/mehdiophthal1413 ◽

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.

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THE EFFECTIVITY OF LEVOBUNOLOL VERSUS TRAVOPROST IN REDUCING INTRAOCULAR PRESSURE

Journal of Medical Sciences ◽

10.52764/jms.21.29.2.06 ◽

2021 ◽

Vol 29 (02) ◽

pp. 93-97

Author(s):

Falak Naz ◽

Muhammad Saleh Faisal ◽

Waheed Iqbal ◽

Momina Naz ◽

Muhammad sajid Khan ◽

...

Keyword(s):

Ocular Hypertension ◽

Primary Open Angle Glaucoma ◽

Open Angle Glaucoma ◽

Demographic Data ◽

P Value ◽

Eye Drops ◽

Open Angle ◽

Efficacy Evaluation ◽

Onset Of Action

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.

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Uveitis and cystoid macular oedema secondary to topical prostaglandin analogue use in ocular hypertension and open angle glaucoma

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2019-315280 ◽

2020 ◽

Vol 104 (8) ◽

pp. 1040-1044

Author(s):

Jason Hu ◽

James Thinh Vu ◽

Brian Hong ◽

Chloe Gottlieb

Keyword(s):

Ocular Hypertension ◽

Case Studies ◽

Macular Oedema ◽

Open Angle Glaucoma ◽

Experimental Studies ◽

Cochrane Library ◽

Cystoid Macular Oedema ◽

Eye Drops ◽

Open Angle ◽

Ocular Surgery

BackgroundOf the side effects of prostaglandin analogues (PGAs), uveitis and cystoid macular oedema (CME) have significant potential for vision loss based on postmarket reports. Caution has been advised due to concerns of macular oedema and uveitis. In this report, we researched and summarised the original data suggesting these effects and determined their incidence.MethodsPreferred Reporting Items for Systematic review and Meta-Analyses guidelines were followed. Studies evaluating topical PGAs in patients with ocular hypertension or open angle glaucoma were included. MEDLINE, PubMed, EMBASE, CINAHL, Web of Science, Cochrane Library, LILACS and ClinicalTrials.gov were searched between 1946 and 2019. Experimental studies, animal studies and randomised studies with other intraocular pressure-lowering eye drops were excluded.Results214 studies (28 232 patients) met the inclusion criteria. Using prospective data, the incidence of uveitis and CME among PGA users were 62/28 232 (0.22%) and 25/28 232 (0.09%), respectively. A higher frequency of both uveitis and CME were found among latanoprost users compared with bimatoprost. There were 21 case studies reporting CME including 48 eyes in 43 patients. 47 of 48 eyes (97.9%) had previous incisional ocular surgery. 8 eyes were re-challenged, of which 7 (87.5%) recurred. 7 case studies reported uveitis in 15 eyes of 10 patients. 7 of 15 eyes (46.7%) were either pseudophakic or aphakic. 6 eyes were re-challenged, and all 6 (100%) recurred.ConclusionsCases of uveitis or CME revealed a confounding effect of ocular surgery, aphakia or subluxed intraocular lens. PGAs may be used in non-surgical patients without concern of causing CME or uveitis. The incidences of PGA-associated CME and uveitis are rare with limited prospective studies on the cause-effect relationship.

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Preservative-Free Latanoprost Eye Drops in Patients with Primary Open-Angle Glaucoma/Ocular Hypertension

Clinical Drug Investigation ◽

10.1007/s40261-014-0203-4 ◽

2014 ◽

Vol 34 (7) ◽

pp. 521-528 ◽

Cited By ~ 18

Author(s):

Mark Sanford

Keyword(s):

Ocular Hypertension ◽

Primary Open Angle Glaucoma ◽

Open Angle Glaucoma ◽

Eye Drops ◽

Open Angle ◽

Preservative Free

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Efficacy and safety of newly developed preservative-free latanoprost 0.005% eye drops versus preserved latanoprost 0.005% in open angle glaucoma and ocular hypertension: 12-week results of a randomized, multicenter, controlled phase III trial

International Journal of Ophthalmology ◽

10.18240/ijo.2021.10.10 ◽

2021 ◽

Vol 14 (10) ◽

pp. 1539-1547

Author(s):

Joon Mo Kim ◽

◽

Ji Woong Lee ◽

Haksu Kyung ◽

Seungsoo Rho ◽

...

Keyword(s):

Ocular Hypertension ◽

Open Angle Glaucoma ◽

Similar Efficacy ◽

Phase Iii ◽

Eye Drops ◽

Open Angle ◽

Phase Iii Trial ◽

Diurnal Iop ◽

Preservative Free

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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