Comparative Study of Dorzotimol Eye Drops, 20 mg/mL + 5 mg/mL Versus Cosopt® Eye Drops, 20 mg/mL + 5 mg/mL

Launched by JADRAN GALENSKI LABORATORIJ D.D. · Jul 26, 2023

Keywords

ClinConnect Summary

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:

1. Abdulaeva Elmira Abdulaevna (Test facility No.4)
2. Eryomina Alyona Victorovna (Test facility No.6)
3. Lisitsyn Alexey Borisovich (Test ...

Gender

ALL

Eligibility criteria

• 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.
• • Intraocular pressure (IOP) level: 22-36 mm Hg (by Goldmann applanation tonometry).
• • Visual acuity 0.3 or better on the tested eye.
• • Taking topical prostaglandin analogs as monotherapy at least 3 months prior to the enrollment into the study and poor IOP control (\> 21 mm Hg) or failure to achieve the target IOP, as estimated by the physician.
• • 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 ingredients (dorzolamide and/or timolol) 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 \> 36 mm Hg or \< 22 mm Hg as at the IOP measuring at 11:00 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).
• • Corneal dystrophies.
• • The patient's participation in another clinical trial for the last 3 months.
• • Sinus bradycardia.
• • Second-degree and third-degree AV block.
• • Cardiogenic shock.
• • Decompensated cardiovascular diseases (angina pectoris \> functional class II, arterial hypertension \[systolic pressure \> 140 mm Hg, diastolic pressure \> 90 mm Hg\]), apparent heart failure.
• • Severe renal failure (CC \< 30 mL/min).
• • Airway hyperresponsiveness, bronchial asthma, history of bronchial asthma, severe chronic obstructive pulmonary disease.
• • Any other systemic or mental disorder/condition (unmanageable arterial hypertension, decompensated diabetes mellitus, severe renal impairment, hyperchloremic acidosis) 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