Bell Katharina, Korb Christina, Butsch Christina, Giers Bert Constantin, Beck Anna, Strzalkowska Alicja, Ruckes Christian, Klingberg Ulrike, Pfeiffer Norbert, Lorenz Katrin
Department of Ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.
Interdisciplinary Center Clinical Trials Mainz, University Medical Center, Johannes Gutenberg-University Mainz, Mainz, Germany.
J Ophthalmol. 2022 Jul 20;2022:5249922. doi: 10.1155/2022/5249922. eCollection 2022.
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.
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.
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.
This study showed the equivalence of the tested generic dorzolamide 2% eye drops solution to the reference product Trusopt® eye drops solution. This trial is registered with (ClinicalTrials.gov (identifier: NCT00878917) on April 9, 2009).
本研究旨在证明2%通用型多佐胺滴眼液与创新制剂（Trusopt®滴眼液）在开角型青光眼或高眼压症患者中的等效性。
这项前瞻性、单中心、双盲、活性对照交叉III期研究纳入了32例患者。洗脱期后，患者被随机分为接受参比产品（Trusopt®）或受试产品（2%多佐胺滴眼液，罗姆制药公司）治疗4周。随后进行洗脱期和交叉治疗。滴眼液每日给药3次。主要疗效终点为平均日间眼压的差异。每次访视时于上午8点、中午12点和下午4点使用Goldmann压平眼压计测量眼压，并通过记录不良事件（AE）评估安全性。通过自我报告和滴眼液瓶称重记录治疗依从性。进行了以治疗、序列、研究周期和序列内患者为效应的方差分析，并进行了一项额外的包括基线眼压的事后协方差分析。
34例患者被随机分组并纳入安全性分析人群。符合方案人群包括32例患者。根据自我报告，所有患者的依从性均>80%。在协方差分析模型下，排除2例虚假报告高治疗依从性的患者后，眼压平均变化的90%置信区间为-0.27 mmHg（-1.17 mmHg至-0.64 mmHg），在可接受范围-1.5 mmHg至+1.5 mmHg之内。两种治疗之间在不良事件的频率或严重程度方面未观察到临床相关差异。
本研究表明，受试的2%通用型多佐胺滴眼液与参比产品Trusopt®滴眼液等效。本试验于2009年4月9日在（ClinicalTrials.gov（标识符：NCT00878917）注册）。
