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NCT05973318
Comparative Study of Dorzotimol Eye Drops, 20 mg/mL + 5 mg/mL Versus Cosopt® Eye Drops, 20 mg/mL + 5 mg/mL
Phase 3 trial testing Dorzotimol eye drops, 20 mg/mL + 5 mg/mL in Primary Open Angle Glaucoma of Both Eyes in 110 participants. Completed in 17 September 2018.
17 September 2018
Quick facts
| Lead sponsor | Jadran Galenski laboratorij d.d. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 110 |
| Start date | 10 April 2017 |
| Primary completion | 17 September 2018 |
| Estimated completion | 17 September 2018 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Dorzotimol eye drops, 20 mg/mL + 5 mg/mL — full drug profile →
- Cosopt eye drops, 20 mg/mL + 5 mg/mL — full drug profile →
Conditions studied
- Primary Open Angle Glaucoma of Both Eyes — all drugs for Primary Open Angle Glaucoma of Both Eyes →
Sponsor
Jadran Galenski laboratorij d.d. — full company profile →
Who can join
Adults 18 to 75, any sex, with Primary Open Angle Glaucoma of Both Eyes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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: * if the efficacy of the investigational drug and the reference drug in patients with ocular hypertension and primary open-angle glaucoma is equal; * if the safety of the investigational drug and the reference drug in patients with ocular hypertension and primary open-angle glaucoma is equal. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05973318
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other Jadran Galenski laboratorij d.d. trials
Trials by the same sponsor.
- NCT07050446 — Vizol S DIGI EYE Efficacy and Safety Study in Patients With Dry Eye · Phase 3 · completed
- NCT06323395 — Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye · Phase 3 · completed
- NCT05973305 — Comparative Study of Dorzol Eye Drops, 20 mg/ml Versus Trusopt® Eye Drops, 20 mg/ml · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05973318 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jadran Galenski laboratorij d.d.
- Last refreshed: 2 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05973318.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing