Status:
COMPLETED
Comparative Study of Dorzol Eye Drops, 20 mg/ml Versus Trusopt® Eye Drops, 20 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 Dorzol 20 mg/mL Eye Drops manufactured by JADRAN-GALENSKI LABORATORIJ d.d. (Croatia) aimed at lowering elevated IOP in patients with ocular ...
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 ...
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.
- 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
- 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.
Key Trial Info
Start Date :
April 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT05973305
Start Date
April 5 2017
End Date
September 1 2018
Last Update
August 2 2023
Active Locations (1)
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1
State autonomous healthcare institution 'Republican Clinical Ophthalmological Hospital of the Ministry of Health of the Republic of Tatarstan'
Kazan', Russia