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35. Internationaler Kongress der Deutschen Ophthalmochirurgie (DOC)

15.06. - 17.06.2023, Nürnberg

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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

Meeting Abstract

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  • Anna Beck - Univ. Medical Center, Johannes Gutenberg-University Mainz, Department of Ophthalmology, Mainz
  • Katharina Bell - Univ. Medical Center, Johannes Gutenberg-University Mainz, Department of Ophthalmology, Mainz
  • Christina Korb - Univ. Medical Center, Johannes Gutenberg-University Mainz, Department of Ophthalmology, Mainz
  • Christina Butsch - Univ. Medical Center, Johannes Gutenberg-University Mainz, Department of Ophthalmology, Mainz
  • Bert Constantin Giers - Univ. Medical Center, Johannes Gutenberg-University Mainz, Department of Ophthalmology, Mainz
  • Alicja Strzalkowska - Univ. Medical Center, Johannes Gutenberg-University Mainz, Department of Ophthalmology, Mainz
  • Christian Ruckes - Univ. Medical Center, Johannes Gutenberg-University Mainz, Interdisciplinary Center Clinical Trials Mainz, Mainz
  • Ulrike Klingbeil - Alfred E. Tiefenbacher GmbH & Co. KG, Hamburg
  • Norbert Pfeiffer - Univ. Medical Center, Johannes Gutenberg-University Mainz, Department of Ophthalmology, Mainz
  • Katrin Lorenz - Univ. Medical Center, Johannes Gutenberg-University Mainz, Department of Ophthalmology, Mainz

35. Internationaler Kongress der Deutschen Ophthalmochirurgie (DOC). Nürnberg, 15.-17.06.2023. Düsseldorf: German Medical Science GMS Publishing House; 2023. DocEPO 2.1

doi: 10.3205/23doc076, urn:nbn:de:0183-23doc0763

Veröffentlicht: 13. Juni 2023

© 2023 Beck et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.

Gliederung

Text

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 was performed. Drops were applied t.i.d. 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, 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 sequence as effects was performed and an additional post-hoc ANCOVA including the baseline IOP.

Results: 34 patients were randomized and analyzed in the safety population. The per protocol population included 32 patients. According to 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, that had falsely reported high therapy adherence. No clinically relevant difference was observed in frequency or severity of the AEs between both treatments.

Conclusion: This study showed the equivalence of the tested generic dorzolamide 2% eye drops solution to the reference product Trusopt® eye drops solution.