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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
DC Field | Value | Language |
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dc.contributor.author | 김찬윤 | - |
dc.date.accessioned | 2021-12-28T16:55:15Z | - |
dc.date.available | 2021-12-28T16:55:15Z | - |
dc.date.issued | 2021-10 | - |
dc.identifier.issn | 2222-3959 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/186852 | - |
dc.description.abstract | 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. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Press of International Journal of Ophthalmology | - |
dc.relation.isPartOf | INTERNATIONAL JOURNAL OF OPHTHALMOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Ophthalmology (안과학교실) | - |
dc.contributor.googleauthor | Joon Mo Kim | - |
dc.contributor.googleauthor | Kyung Rim Sung | - |
dc.contributor.googleauthor | Ji Woong Lee | - |
dc.contributor.googleauthor | Haksu Kyung | - |
dc.contributor.googleauthor | Seungsoo Rho | - |
dc.contributor.googleauthor | Chan Yun Kim | - |
dc.identifier.doi | 10.18240/ijo.2021.10.10 | - |
dc.contributor.localId | A01035 | - |
dc.relation.journalcode | J03008 | - |
dc.identifier.eissn | 2227-4898 | - |
dc.identifier.pmid | 34667730 | - |
dc.subject.keyword | benzalkonium chloride | - |
dc.subject.keyword | intraocular pressure | - |
dc.subject.keyword | latanoprost | - |
dc.subject.keyword | preservative-free | - |
dc.contributor.alternativeName | Kim, Chan Yun | - |
dc.contributor.affiliatedAuthor | 김찬윤 | - |
dc.citation.volume | 14 | - |
dc.citation.number | 10 | - |
dc.citation.startPage | 1539 | - |
dc.citation.endPage | 1547 | - |
dc.identifier.bibliographicCitation | INTERNATIONAL JOURNAL OF OPHTHALMOLOGY, Vol.14(10) : 1539-1547, 2021-10 | - |
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