Efficacy and safety of preoperative IOP reduction using a preservative-free fixed combination of dorzolamide/timolol eye drops versus oral acetazolamide and dexamethasone eye drops and assessment of the clinical outcome of trabeculectomy in glaucoma

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.

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Effectiveness of a Preservative-Free Eye Drop, Cyclosporine 0.05% Emulsion, and Omega-3 Supplementation as a Fixed Combination in Dry Eye Disease – a Pilot Study

Current Trends in Ophthalmology ◽

10.18314/ctoy.v1i1.151 ◽

2018 ◽

Vol 1 (1) ◽

pp. 01-06

Author(s):

Tokko HA ◽

Al-Awadi A ◽

Somani S

Keyword(s):

Dry Eye ◽

Fixed Combination ◽

Case Series ◽

Secondary Outcome ◽

Combination Regimen ◽

Eye Drops ◽

Secondary Outcome Measure ◽

Omega 3 ◽

The Impact ◽

Preservative Free

Purpose: We aim to evaluate the impact of combining a preservative-free drop, cyclosporine 0.05% emulsion, and omega-3 oral supplementation on the signs and symptoms of dry eye in a typical ophthalmic practice.Design: A retrospective case series conducted on patients with dry eye disease.Methods: Patients diagnosed with dry eye in a typical ophthalmology practice were initiated on a fixed combination regimen which included a preservative-free eye drop (I-DROP ® PUR GEL, I-MED pharma), cyclosporine 0.05% ophthalmic emulsion, and oral omega-3 supplement(Dry Eye Omega Benefits®, PRN)for 3 monthsconsecutively. The primary outcome measured was a symptom score using the Canadian Dry Eye Assessment Tool (CDEA). Secondary outcome measure was Non-invasive Keratograph Break-up Time (NIKBUT). Primary and secondary outcomes measured at baseline and 3 months following intervention were compared.Results: Thirty-six patients were included with a female male ratio of 2.6:1 and average age of 64.Patient symptoms improved significantly following the intervention as demonstrated by a lower CDEA score during the second visit compared to the first visit (16.11 vs. 19.50, respectively) (p< .05). NIKBUT scores were also significantly improved as demonstrated by a higher score during the second visit compared to the first in both the right (13.18 vs. 11.44) (p< .05) and left (14.62 vs. 12.78) (p< .01) eyes, respectively.Conclusion: A fixed combination of preservative-free eye drops, cyclosporine 0.05% and omega-3 supplementation may be an effective first line treatment option in alleviating symptoms and improving signs of patients suffering from dry eye.

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Noninferiority of Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients With Open-angle Glaucoma or Ocular Hypertension

Journal of Glaucoma ◽

10.1097/ijg.0000000000001248 ◽

2019 ◽

Vol 28 (6) ◽

pp. 498-506

Author(s):

Florent Aptel ◽

Norbert Pfeiffer ◽

Stefanie Schmickler ◽

Jonathan Clarke ◽

Cosme Lavín-Dapena ◽

...

Keyword(s):

Ocular Hypertension ◽

Fixed Combination ◽

Open Angle Glaucoma ◽

Eye Drops ◽

Open Angle ◽

Preservative Free

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Efficacy and Tolerability of Preservative-Free Eye Drops Containing a Fixed Combination of Dorzolamide and Timolol in Glaucoma Patients

Journal of Ocular Pharmacology and Therapeutics ◽

10.1089/jop.2010.0060 ◽

2010 ◽

Vol 26 (6) ◽

pp. 597-603 ◽

Cited By ~ 14

Author(s):

Giulia Renieri ◽

Katrin Führer ◽

Karl Scheithe ◽

Katrin Lorenz ◽

Norbert Pfeiffer ◽

...

Keyword(s):

Fixed Combination ◽

Eye Drops ◽

Preservative Free

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Efficacy and safety evaluation of benzalkonium chloride preserved eye-drops compared with alternatively preserved and preservative-free eye-drops in the treatment of glaucoma: a systematic review and meta-analysis

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2019-315623 ◽

2020 ◽

pp. bjophthalmol-2019-315623 ◽

Cited By ~ 1

Author(s):

Anne Hedengran ◽

Alvilda T Steensberg ◽

Gianni Virgili ◽

Augusto Azuara-Blanco ◽

Miriam Kolko

Keyword(s):

Systematic Review ◽

Benzalkonium Chloride ◽

Data Extraction ◽

Meta Analysis ◽

Risk Of Bias ◽

Selective Reporting ◽

Eye Drops ◽

Efficacy And Safety ◽

Safety Measures ◽

Preservative Free

Background/aimsThis systematic review compared the efficacy and safety of benzalkonium chloride (BAK)-preserved eye-drops with alternatively preserved (AP) and preservative-free (PF) eye-drops.MethodsPubMed, EMBASE and MEDLINE were searched for randomised controlled trials in June and October 2019. Study selection, data extraction and risk of bias assessment were made by two independent reviewers using the Cochrane Handbook. Studies on prostaglandin analogue or beta-blocker eye-drops and patients with glaucoma or ocular hypertension were included. Primary outcome was change in intraocular pressure (IOP). Secondary outcomes were safety measures as assessed in original study.ResultsOf 433 articles screened, 16 studies were included. IOP meta-analysis was conducted on 13 studies (4201 patients) ranging from 15 days to 6 months. No significant differences between BAK versus PF and AP were identified (95% CI −0.00 to 0.30 mm Hg, p=0.05). Meta-analyses revealed no differences between BAK versus AP and PF with regards to conjunctival hyperaemia (risk ratio (RR) 1.05, 95% CI 0.91 to 1.22, 3800 patients, 9 studies), ocular hyperaemia (RR 1.31, 95% CI 0.96 to 1.78, 2268 patients, 5 studies), total ocular adverse events (RR 1.03, 95% CI 0.88 to 1.20, 1906 patients, 5 studies) or tear break-up time (mean difference 0.89, 95% CI −0.03 to 1.81, 130 patients, 3 studies). Diverse reporting on safety measures made comparison challenging. Risk of bias was assessed as high or unclear in many relevant domains, suggesting potential selective reporting or under-reporting.ConclusionNo clinically significant differences on efficacy or safety could be determined between BAK versus AP and PF. However, there were substantial uncertainties on safety.PROSPERO registration numberCRD42019139692

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Pharmacokinetics, Efficacy, and Safety of the Preservative-free Fixed Combination of Tafluprost 0.0015 % and Timolol 0.5 % in Healthy Volunteers: A Phase I Comparison vs. the Corresponding Preservative-free Monotherapies

Clinical Pharmacokinetics ◽

10.1007/s40262-015-0331-x ◽

2015 ◽

Vol 55 (4) ◽

pp. 485-494 ◽

Cited By ~ 8

Author(s):

Kai Kaarniranta ◽

Kirsi Ikäheimo ◽

Eliisa Mannermaa ◽

Auli Ropo

Keyword(s):

Phase I ◽

Healthy Volunteers ◽

Fixed Combination ◽

Efficacy And Safety ◽

Preservative Free

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Efficacy and Safety of Netilmycin/Dexamethasone Preservative-Free and Tobramycin/Dexamethasone-Preserved Fixed Combination in Patients After Cataract Surgery

Journal of Ocular Pharmacology and Therapeutics ◽

10.1089/jop.2010.0050 ◽

2010 ◽

Vol 26 (6) ◽

pp. 617-621 ◽

Cited By ~ 11

Author(s):

Veronica Pianini ◽

Andrea Passani ◽

Gemma C.M. Rossi ◽

Franco Passani

Keyword(s):

Cataract Surgery ◽

Fixed Combination ◽

Efficacy And Safety ◽

Preservative Free

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Comparison of Ocular Surface Cytological Appearance in Glaucoma Patient Treated with Timolol Maleat 0,5% Latanoprost 0,005% and Timolol-Latanoprost Fixed Combination Preservative Free Eye Drop

Ophthalmologica Indonesiana ◽

10.35749/journal.v44i2.167 ◽

2019 ◽

Vol 44 (2) ◽

pp. 82

Author(s):

Maretha Amrayni ◽

Elsa Gustianty ◽

Susi Heryati ◽

Andika Prahasta ◽

Maula Rifada ◽

...

Keyword(s):

Epithelial Cells ◽

Cell Density ◽

Goblet Cell ◽

Ocular Surface ◽

Fixed Combination ◽

Cell Contact ◽

Corneal Epithelial ◽

Preservative Free ◽

Goblet Cell Density ◽

Epithelial Metaplasia

Introduction : The longterm use of topical antiglaucoma might cause ocular surface instability due to active substance or preservative used. Impression cytology examination may reveal superficial epithelial cells on conjunctiva and cornea, including goblet cells. Goblet cell density decrease is the most important parameter on evaluation of ocular surface disorder. Objective : This study was to understand ocular surface remodeling due to active substance of topical antiglaucoma with impression cytology examination among the patient prior and 3 months after therapy. Methods : This was a randomized controlled trial study with single blind masking. A total of 45 eyes from 31 patients were used as subject and distributed onto three groups treatment, which were timolol maleat 0.5%, latanoprost 0.005%, and latanoprost-timolol maleat fixed combination. All topical antiglaucoma in this study were preservative free. Result : There were differences between 3 groups in goblet cells density after 3 months therapy (p=0,030). Goblet cell density in timolol group was lower than latanoprost (p=0,041) and fixed combination (p=0,045). There was no significantly difference between 3 groups in conjunctival epithelial metaplasia degree (p=0,706) and cell to cell contact degree in corneal epithelial cells (p=0.66) after 3 months therapy. Conjunctival epithelial metaplasia degree were increased among group of timolol (p=0,008) and fixed combination (p=0,046). Conclusion : Timolol maleat 0,5% caused lower goblet cell density after 3 months therapy compare with latanoprost and fixed combination. There was no significantly difference in conjunctival epithelial metaplasia and cell to cell contact degree in corneal epithelial cells among these glaucoma treatment groups.

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Comparative efficacy and safety of preserved versus preservative‐free beta‐blockers in patients with glaucoma or ocular hypertension: a systematic review

Acta Ophthalmologica ◽

10.1111/aos.14926 ◽

2021 ◽

Author(s):

Anne Guldhammer Skov ◽

Amalie Santaolalla Rives ◽

Josefine Freiberg ◽

Gianni Virgili ◽

Augusto Azuara‐Blanco ◽

...

Keyword(s):

Systematic Review ◽

Ocular Hypertension ◽

Beta Blockers ◽

Efficacy And Safety ◽

Comparative Efficacy ◽

Preservative Free

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Comparison of adherence between fixed and unfixed topical combination glaucoma therapies using Japanese healthcare/pharmacy claims database: a retrospective non-interventional cohort study

BMC Ophthalmology ◽

10.1186/s12886-021-01813-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Chikako Shirai ◽

Nobushige Matsuoka ◽

Toru Nakazawa

Keyword(s):

Cohort Study ◽

Real World ◽

Fixed Combination ◽

Japanese Patients ◽

Eye Drops ◽

Combination Therapies ◽

Real World Data ◽

Healthcare Database ◽

Pharmacy Claims ◽

Persistence Rate

Abstract Background Adherence to chronic therapies is crucial to prevent the progression of disease, such as glaucoma. However, only a limited number of studies have investigated them using real-world data in Japan. This study aimed to evaluate Japanese patients’ adherence to fixed- and unfixed-combination eye drops as a second-line therapy for glaucoma in real-world practice. Methods This retrospective, non-interventional cohort study utilized a commercially available Japanese healthcare database (MinaCare database). Medical/pharmacy claims data were collected from 2011 to 2016. The primary endpoint was adherence to medications, assessed by proportion of days covered (PDC) with medication during a 12-month post-index period. Meanwhile, the secondary endpoints included the persistence rate. Results A total of 738 patients were included in this study: 309 and 329 in the fixed- and unfixed-combination cohorts, respectively. Prostaglandin analog (PG)/β-blocker (BB) was most commonly claimed in 241/309 (78.0%) patients in the fixed-combination cohort. In the unfixed-combination cohort, PG and BB were claimed in 130/329 (39.5%) patients, whereas PG and α2-agonist were claimed in 87/329 (26.4%) patients. Patients were more adherent to the fixed-combination than the unfixed-combinations (mean PDCs [SD], 79.1% [32.1] vs. 62.2% [38.0]; P < 0.0001). The proportion of patients with good adherence (PDC ≥ 80%) was also higher in the fixed-combination cohort (69.6%) than in the unfixed-combination cohort (48.6%) (P < 0.0001). During the 12-month post-index period, the persistence rate was higher in the fixed-combination cohort than in the unfixed-combination cohort (47.6% [95% confidence intervals (CI): 41.9–53.0] vs. 24.9% [95% CI: 20.4–29.7], P < 0.0001). Conclusions Japanese patients with glaucoma preferred the fixed-combination therapies over the unfixed-combination therapies. Hence, fixed-combination therapies would contribute to the improvement of adherence.

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