PMID- 35909461
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220802
IS  - 2090-004X (Print)
IS  - 2090-0058 (Electronic)
IS  - 2090-004X (Linking)
VI  - 2022
DP  - 2022
TI  - A Randomized, Double-Masked, Active-Controlled, Crossover Phase III Equivalence 
      Study of Generic Dorzolamide 2% versus Innovator Trusopt(R) Eye Drop Solution in 
      Subjects with Open-Angle Glaucoma or Ocular Hypertension.
PG  - 5249922
LID - 10.1155/2022/5249922 [doi]
LID - 5249922
AB  - BACKGROUND: The aim of this study was to demonstrate the equivalence of generic 
      dorzolamide 2% eye drops solution versus the innovator formulation (Trusopt(R) 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(R)) 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(R) eye drops solution. Trial 
      Registration. This trial is registered with (ClinicalTrials.gov (identifier: 
      NCT00878917) on April 9, 2009).
CI  - Copyright (c) 2022 Katharina Bell et al.
FAU - Bell, Katharina
AU  - Bell K
AUID- ORCID: 0000-0003-4127-1635
AD  - Department of Ophthalmology, University Medical Center, Johannes 
      Gutenberg-University Mainz, Mainz, Germany.
FAU - Korb, Christina
AU  - Korb C
AUID- ORCID: 0000-0001-7572-4749
AD  - Department of Ophthalmology, University Medical Center, Johannes 
      Gutenberg-University Mainz, Mainz, Germany.
FAU - Butsch, Christina
AU  - Butsch C
AD  - Department of Ophthalmology, University Medical Center, Johannes 
      Gutenberg-University Mainz, Mainz, Germany.
FAU - Giers, Bert Constantin
AU  - Giers BC
AUID- ORCID: 0000-0001-5849-016X
AD  - Department of Ophthalmology, University Medical Center, Johannes 
      Gutenberg-University Mainz, Mainz, Germany.
FAU - Beck, Anna
AU  - Beck A
AUID- ORCID: 0000-0003-0365-3819
AD  - Department of Ophthalmology, University Medical Center, Johannes 
      Gutenberg-University Mainz, Mainz, Germany.
FAU - Strzalkowska, Alicja
AU  - Strzalkowska A
AUID- ORCID: 0000-0001-5536-5849
AD  - Department of Ophthalmology, University Medical Center, Johannes 
      Gutenberg-University Mainz, Mainz, Germany.
FAU - Ruckes, Christian
AU  - Ruckes C
AUID- ORCID: 0000-0003-4823-0430
AD  - Interdisciplinary Center Clinical Trials Mainz, University Medical Center, 
      Johannes Gutenberg-University Mainz, Mainz, Germany.
FAU - Klingberg, Ulrike
AU  - Klingberg U
AD  - Alfred E. Tiefenbacher GmbH & Co. KG, Hamburg, Germany.
FAU - Pfeiffer, Norbert
AU  - Pfeiffer N
AUID- ORCID: 0000-0002-5766-2617
AD  - Department of Ophthalmology, University Medical Center, Johannes 
      Gutenberg-University Mainz, Mainz, Germany.
FAU - Lorenz, Katrin
AU  - Lorenz K
AUID- ORCID: 0000-0002-1755-7396
AD  - Department of Ophthalmology, University Medical Center, Johannes 
      Gutenberg-University Mainz, Mainz, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT00878917
PT  - Journal Article
DEP - 20220720
PL  - United States
TA  - J Ophthalmol
JT  - Journal of ophthalmology
JID - 101524199
PMC - PMC9329021
COIS- Ulrike Klingberg is an employee of the sponsor of the study. The other authors 
      declare that they have no conflicts of interest.
EDAT- 2022/08/02 06:00
MHDA- 2022/08/02 06:01
PMCR- 2022/07/20
CRDT- 2022/08/01 03:15
PHST- 2022/01/12 00:00 [received]
PHST- 2022/06/13 00:00 [revised]
PHST- 2022/06/28 00:00 [accepted]
PHST- 2022/08/01 03:15 [entrez]
PHST- 2022/08/02 06:00 [pubmed]
PHST- 2022/08/02 06:01 [medline]
PHST- 2022/07/20 00:00 [pmc-release]
AID - 10.1155/2022/5249922 [doi]
PST - epublish
SO  - J Ophthalmol. 2022 Jul 20;2022:5249922. doi: 10.1155/2022/5249922. eCollection 
      2022.