A Randomized, Open-label, Controlled, Comparative Study of Efficacy and Safety of Dorzol Eye Drops, 20 mg/mL (JGL dd, Croatia) vs Trusopt® Eye Drops, 20 mg/mL (Merck Sharp & Dohme, France) in Patients With Primary Open-angle Glaucoma
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- Mean IOP change from baseline
Study Overview
Brief Summary
The goal of this study is to compare efficacy and safety of Dorzol 20 mg/mL Eye Drops 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 TRUSOPT 20 MG/ML Eye Drops 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 118 participants were screened and randomized 1:1 to the investigational drug (Dorzol) group or the reference drug (Trusopt) group. 59 patients were recruited in each group.
Researchers compared the investigational drug (Dorzol) group with the reference drug (Trusopt) 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.
Detailed Description
Study Title:
A randomized, open-label, controlled, comparative study of efficacy and safety of Dorzol eye drops, 20 mg/mL, manufacturer: JADRAN - GALENSKI LABORATORIJ d.d., Croatia, vs. Trusopt® eye drops, 20 mg/mL, manufacturer: Laboratoires Merck Sharp & Dohme-Chibret, France, in patients with primary open-angle glaucoma.
Protocol No. DORZOL-10/2015, version No. 1.0 of 25.10.2015 RCT No. 629 of 07.09.2016 Investigators
- Abdulaeva Elmira Abdulaevna (Test facility No.4)
- Eryomina Alyona Victorovna (Test facility No.6)
- Lisitsyn Alexey Borisovich (Test facility No.7)
- Doga Alexander Victorovich (Test facility No.8) 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Females or males in the age bracket of 18 to 75 years.
- •Established stage I and II primary open-angle glaucoma in one or both eyes.
- •IOP = 21-27 mm Hg (by Goldmann applanation tonometry).
- •Visual acuity 0.3 or better on the tested eye.
- •Patients who have signed an informed consent to participate in the study.
- •For females of child-bearing potential - a negative pregnancy test and consent to use reliable contraception methods throughout the study.
Exclusion Criteria
- •Contraindications or hypersensitivity to the active ingredient (dorzolamide) or excipients.
- •The only eye.
- •Visual acuity ˂ 0.3 after correction.
- •An active infectious inflammatory process on the tested eye within 3 months prior to pre-study medical examination.
- •Pronounced visual field defects (III and IV stage open-angle glaucoma).
- •IOP ˃ 27 mm Hg or ˂ 21 mm Hg as at the IOP measuring at 10.00 a.m. (±1 h) in any of the eyes on the screening visit day.
- •Closed or nearly closed anterior chamber angle (ACA) or history of acute angle close.
- •Surgical and laser eye interventions over the last 3 months.
- •Manifest ocular media opacification hindering the treatment efficacy evaluation.
- •Other eye diseases that may affect dynamics of the parameters used for the treatment efficacy evaluation.
- •Inflammatory conditions of the eye and appendages (blepharitis, conjunctivitis).
- •Chronic kidney disease (creatinine clearance ˂ 30 mL/min).
- •Hyperchloremic acidosis.
- •Concomitant administration of oral carbonic anhydrase inhibitors.
- •Children and adolescents under 18 years.
- •The patient's participation in another clinical trial for the last 3 months.
- •Any systemic or mental disorder/condition (unmanageable arterial hypertension, decompensated diabetes mellitus, severe renal impairment) or clinically relevant abnormal laboratory tests at screening that, in the Investigator's opinion, may put a patient to a significant risk, or compromise the study results, or appreciably affect the possibility for the patient to participate in the study.
- •A patient who is unlikely to comply with the protocol requirements, e.g., is undisposed to cooperation, and is unlikely to complete the study.
- •Females and males of reproductive age refusing to use efficacious contraception methods.
- •Females during pregnancy and breastfeeding.
Arms & Interventions
Patients with primary open-angle glaucoma receiving Dorzol 20 mg/ml
Dorzol 20 mg/ml eye drops, dosing schedule t.i.d, 12 weeks
Intervention: Dorzol 20 mg/ml (Drug)
Patients with primary open-angle glaucoma receiving Trusopt 20 mg/ml
Trusopt 20 mg/ml eye drops, dosing schedule t.i.d, 12 weeks
Intervention: Trusopt 20 mg/ml (Drug)
Outcomes
Primary Outcomes
Mean IOP change from baseline
Time Frame: 12 weeks
Mean change in intraocular pressure (IOP) at visit 5 compared to baseline at visit 0
Secondary Outcomes
- IOP reduction rate to the target level of ≤ 18 mm Hg(12 weeks)
- IOP reduction rate by more than 20%(12 weeks)
- IOP reduction rate by more than 30%(12 weeks)