Gutenberg Open Science: A randomized, double-masked, active-controlled, crossover phase III equivalence study of generic dorzolamide 2% versus innovator Trusopt® eye drop solution in subjects with open-angle glaucoma or ocular hypertension

Please use this identifier to cite or link to this item: http://doi.org/10.25358/openscience-8602

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DC Field	Value	Language
dc.contributor.author	Bell, Katharina	-
dc.contributor.author	Korb, Christina	-
dc.contributor.author	Butsch, Christina	-
dc.contributor.author	Giers, Bert Constantin	-
dc.contributor.author	Beck, Anna	-
dc.contributor.author	Strzalkowska, Alicja	-
dc.contributor.author	Ruckes, Christian	-
dc.contributor.author	Klingberg, Ulrike	-
dc.contributor.author	Pfeiffer, Norbert	-
dc.contributor.author	Lorenz, Katrin	-
dc.date.accessioned	2023-01-20T08:53:26Z	-
dc.date.available	2023-01-20T08:53:26Z	-
dc.date.issued	2022	-
dc.identifier.uri	https://openscience.ub.uni-mainz.de/handle/20.500.12030/8618	-
dc.description.abstract	Background. The aim of this study was to demonstrate the equivalence of generic dorzolamide 2% eye drops solution versus the innovator formulation (Trusopt® eye drops solution) in patients with open-angle glaucoma or ocular hypertension. Methods. This prospective, monocentric, double-masked, active-controlled crossover phase III study included 32 patients. After washout, patients were randomized to reference product (Trusopt®) or test product (dorzolamide 2% eye drops, Rompharm Company SRL) for a 4-week period. Subsequent washout and crossover were performed. Drops were applied t.i.d. The primary efficacy endpoint was the difference in mean diurnal IOP. Goldmann applanation tonometry was performed at 8 am, 12 pm, and 4 pm at each visit, and safety was assessed by documentation of adverse events (AEs). Therapy adherence was documented by self-reporting and eye drop bottle weighing. An ANOVA with treatment, sequence, study period, and patient within the sequence as effects was performed and an additional post hoc ANCOVA including the baseline IOP was also performed. Results. 34 patients were randomized and analyzed in the safety population. The per-protocol population included 32 patients. According to the self-report, all patients were >80% compliant. Under the ANCOVA model, the 90% confidence interval for the average change of the IOP −0.27 mmHg (−1.17 mmHg–0.64 mmHg) is included by the acceptance range −1.5 mmHg to +1.5 mmHg after excluding 2 patients, which had falsely reported high therapy adherence. No clinically relevant difference was observed in frequency or severity of the AEs between both treatments. Conclusions. This study showed the equivalence of the tested generic dorzolamide 2% eye drops solution to the reference product Trusopt® eye drops solution. Trial Registration. This trial is registered with (ClinicalTrials.gov (identifier: NCT00878917) on April 9, 2009).	en_GB
dc.description.sponsorship	Gefördert durch die Deutsche Forschungsgemeinschaft (DFG) - Projektnummer 491381577	de
dc.language.iso	eng	de
dc.rights	CC BY	*
dc.rights.uri	https://creativecommons.org/licenses/by/4.0/	*
dc.subject.ddc	610 Medizin	de_DE
dc.subject.ddc	610 Medical sciences	en_GB
dc.title	A randomized, double-masked, active-controlled, crossover phase III equivalence study of generic dorzolamide 2% versus innovator Trusopt® eye drop solution in subjects with open-angle glaucoma or ocular hypertension	en_GB
dc.type	Zeitschriftenaufsatz	de
dc.identifier.doi	http://doi.org/10.25358/openscience-8602	-
jgu.type.contenttype	Scientific article	de
jgu.type.dinitype	article	en_GB
jgu.type.version	Published version	de
jgu.type.resource	Text	de
jgu.organisation.department	FB 04 Medizin	de
jgu.organisation.number	2700	-
jgu.organisation.name	Johannes Gutenberg-Universität Mainz	-
jgu.rights.accessrights	openAccess	-
jgu.journal.title	Journal of ophthalmology	de
jgu.journal.volume	2022	de
jgu.pages.alternative	5249922	de
jgu.publisher.year	2022	-
jgu.publisher.name	Hindawi	de
jgu.publisher.place	New York, NY	de
jgu.publisher.issn	2090-004X	de
jgu.publisher.issn	2090-0058	de
jgu.organisation.place	Mainz	-
jgu.subject.ddccode	610	de
jgu.publisher.doi	10.1155/2022/5249922	de
jgu.organisation.ror	https://ror.org/023b0x485	-
jgu.subject.dfg	Lebenswissenschaften	de
Appears in collections:	DFG-491381577-G

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