Comparative Study of Dorzotimol Eye Drops, 20 mg/mL + 5 mg/mL Versus Cosopt® Eye Drops, 20 mg/mL + 5 mg/mL
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ClinicalTrials.gov Identifier: NCT05973318 |
Recruitment Status :
Completed
First Posted : August 2, 2023
Last Update Posted : August 2, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | July 26, 2023 | ||||
First Posted Date ICMJE | August 2, 2023 | ||||
Last Update Posted Date | August 2, 2023 | ||||
Actual Study Start Date ICMJE | April 10, 2017 | ||||
Actual Primary Completion Date | September 17, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Mean IOP change from baseline [ Time Frame: 12 weeks ] Mean IOP change from baseline on visit 5 comparing with visit 0
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Comparative Study of Dorzotimol Eye Drops, 20 mg/mL + 5 mg/mL Versus Cosopt® Eye Drops, 20 mg/mL + 5 mg/mL | ||||
Official Title ICMJE | An Open-label, Randomized, Controlled, Comparative Efficacy and Safety Study of Dorzotimol Eye Drops, 20 mg/mL + 5 mg/mL (JGL dd, Croatia), vs. Cosopt® Eye Drops, 20 mg/mL + 5 mg/mL (Merck Sharp & Dohme, France) in Patients With POAG | ||||
Brief Summary | The goal of this study is to compare efficacy and safety of Dorzotimol eye drops, 20 mg/mL + 5 mg/mL manufactured by JADRAN-GALENSKI LABORATORIJ d.d. (Croatia) aimed at lowering elevated IOP in patients with ocular hypertension and primary open-angle glaucoma (POAG) versus Cosopt® eye drops, 20 mg/mL + 5 mg/mL manufactured by Laboratoires Merck Sharp & Dohme-Chibret, France. The main questions it aims to answer are:
A total of 110 participants were screened and randomized 1:1 to the investigational drug (Dorzotimol) group or the reference drug (Cosopt) group. 55 patients were recruited in each group. Researchers compared the investigational drug (Dorzotimol) group with the reference drug (Cosopt) group to see if the efficacy and safety of the investigational drug and the reference drug in patients with ocular hypertension and primary open-angle glaucoma are equal. |
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Detailed Description | Study Title: An open-label, randomized, controlled, comparative efficacy and safety study of Dorzotimol eye drops, 20 mg/mL + 5 mg/mL, manufacturer: JADRAN - GALENSKI LABORATORIJ d.d., Croatia, vs. Cosopt® eye drops, 20 mg/mL + 5 mg/mL, manufacturer: Laboratoires Merck Sharp & Dohme-Chibret, France, in patients with primary open-angle glaucoma. Protocol No. DORZOTIMOL-10/2015, version No. 1.2 of 16.05.2017. RCT No. 632 of 09.09.2016. Investigators:
Test facilities: No.4. State autonomous healthcare institution 'Republican Clinical Ophthalmological Hospital of the Ministry of Health of the Republic of Tatarstan', 420012, Republic of Tatarstan, Kazan, Butlerova St., 14. No.6. Federal state autonomous institution 'Acad. S.N. Fyodorov Eye Microsurgery Interbranch Science and Technology Complex', Ministry of Health of the Russian Federation, 127486, Moscow, Beskudnikovsky Blvd., 59A (branch: 630071, Novosibirsk, Kolkhidskaya St., 10). No.7. State healthcare institution of Yaroslavl region 'Clinical Hospital No. 8', 150030, Yaroslavl, Suzdalskoe Highway, 39. No.9. Federal state autonomous institution 'Acad. S.N. Fyodorov Eye Microsurgery Interbranch Science and Technology Complex', Ministry of Health of the Russian Federation, 127486, Moscow, Beskudnikovsky Blvd., 59A Study period: First patient enrollment date: 10 April 2017 Study completion date: 17 September 2018 Phase: III (a safety and efficacy study) Study objective: The study objective was to evaluate the efficacy and safety of Dorzotimol eye drops, 20 mg/mL + 5 mg/mL, manufacturer: JADRAN - GALENSKI LABORATORIJ d.d., Croatia, designed to reduce elevated intraocular pressure in patients with primary open-angle glaucoma (POAG), vs. Cosopt® eye drops, 20 mg/mL + 5 mg/mL, manufacturer: Laboratoires Merck Sharp & Dohme-Chibret, France. Study tasks:
Study design: A multicenter, prospective, open-label, randomized, comparative, controlled, parallel-arm study evaluating the efficacy and safety in patients with a specific disease. Study subjects: 110 patients (55 patients in each group) with elevated intraocular pressure induced by primary open-angle glaucoma (POAG), males and females in the age bracket of 18 to 75 years conforming to the inclusion/exclusion criteria. Patients randomized: 110 Dropouts: 0 Per protocol population: 110 Safety population: 110 Drug therapy type Test product: Trade name: Dorzotimol INN or generic name: dorzolamide+timolol Pharmaceutical form: eye drops Composition per 1 mL: Active ingredients: dorzolamide hydrochloride 22.25 mg (equivalent to dorzolamide 20 mg), timolol maleate 6.83 mg (equivalent to timolol 5 mg). Excipients: benzalkonium chloride (as 50% solution), mannitol, sodium citrate, sodium hydroxide, hydroxyethyl cellulose, purified water. Manufacturer: JADRAN - GALENSKI LABORATORIJ d.d., Croatia Posology and method of administration: Instillation into the conjunctival sac of 1 drop twice daily for 12 weeks. Reference product description and labeling: Trade name: Cosopt® INN or generic name: dorzolamide+timolol Pharmaceutical form: eye drops Composition: Active ingredients: dorzolamide 20 mg (dorzolamide hydrochloride 22.26 mg) and timolol 5 mg (timolol maleate 6.83 mg). Excipients: benzalkonium chloride (as 50% benzalkonium chloride solution) 0.075 mg (0.15 mg), sodium citrate 2.94 mg, mannitol 16.00 mg, hyetellose (hydroxyethyl cellulose) 4.75 mg, 1M sodium hydroxide solution q.s. to рН 5.6, water for injection q.s. to 1 mL. Manufacturer: Laboratoires Merck Sharp & Dohme-Chibret, France Study duration: Screening: 7 days. Washout period: 7 days. The comparison product treatment lasted for 12 weeks (84±2 days), which was consistent with the reference product PIL. Follow-up period for safety evaluation: 7 days. The overall study duration per patient did not exceed 100 days. The efficacy was established based on analysis of the parameters as follows: Primary endpoint
Statistical analysis Statistical analysis was performed using Statsoft Statistica Professional 13 and Microsoft Excel 2016 software. The Shapiro-Wilk test was used to evaluate the normality of distribution of quantitative attributes. Parametric tests were used for testing statistical hypotheses for parameters with the normal distribution, whereas nonparametric tests were used for parameters with the variance of the distribution. Student's t-test and Mann-Whitney U test were used for comparing the study groups in terms of quantitative attributes. The comparison of intragroup parameters before and after treatment was performed using the dependent samples t-test or the Wilcoxon test. The intragroup comparisons were also performed using nonparametric repeated measures ANOVA (the Friedman test). Qualitative attributes were analyzed using Pearson's χ2 test or Fisher's exact test (if the attribute incidence rate in at least one subgroup was ≤ 5). Statistically significant are differences with p-values < 0.05. Efficacy analysis of the comparison products provides for a conclusion on • Noninferiority of the test product Dorzotimol, eye drops (JADRAN - GALENSKI LABORATORIJ d.d., Croatia) vs. reference product Cosopt®, eye drops (Laboratoires Merck Sharp & Dohme-Chibret, France) by the primary endpoint:
Intergroup efficacy comparisons of the comparison products by the secondary endpoints have also been performed, with statistical significance of intergroup differences evaluated:
The product safety was assessed from the vital parameters evaluation results, laboratory test and instrumental monitoring data as well as the adverse event occurrence and severity. The safety evaluation provided for the conclusions as follows:
Thus, based on all criteria specified in the Clinical Trial Protocol, the test product Dorzotimol and reference product Cosopt® demonstrate close efficacy and safety parameters. There are no statistically significant intergroup differences by any efficacy criteria tested. The efficacy differences between the test and reference product by the primary criterion do not exceed the noninferiority margin of 1.5 mm Hg. The above-stated provides for a conclusion on the test product Dorzotimol noninferiority vs. reference product Cosopt®. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Primary Open Angle Glaucoma of Both Eyes | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
110 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | September 17, 2018 | ||||
Actual Primary Completion Date | September 17, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:• Contraindications or hypersensitivity to the active ingredients (dorzolamide and/or timolol) or excipients.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Russian Federation | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05973318 | ||||
Other Study ID Numbers ICMJE | DORZOTIMOL-10/2015 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Jadran Galenski laboratorij d.d. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Jadran Galenski laboratorij d.d. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Jadran Galenski laboratorij d.d. | ||||
Verification Date | July 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |