Status:
COMPLETED
Comparative Study of Dorzotimol Eye Drops, 20 mg/mL + 5 mg/mL Versus Cosopt® Eye Drops, 20 mg/mL + 5 mg/mL
Lead Sponsor:
Jadran Galenski laboratorij d.d.
Conditions:
Primary Open Angle Glaucoma of Both Eyes
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 patien...
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. C...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
April 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2018
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05973318
Start Date
April 10 2017
End Date
September 17 2018
Last Update
August 2 2023
Active Locations (1)
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1
Republican Clinical Ophthalmological Hospital of the Ministry of Health of the Republic of Tatarstan
Kazan', Russia