This study will evaluate and confirm that the efficacy and tolerability of the generic formulation Dorzo-Vision® sine Preservative-Free Eye Drops solution is not worse to the marketed preservative free formulation Trusopt® Eye Drops solution in Patients with Open Angle Glaucoma or Ocular Hypertension already on Treatment with IOP-lowering Drugs and Low Intraocular Pressure (IOP=21 mmHg)
- Conditions
- Open angle glaucoma or ocular hypertensionMedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2019-000913-35-GR
- Lead Sponsor
- BECRO (Cyprus) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
-Male or female, of any race and =18 years of age;
-Diagnosed of unilateral or bilateral open angle glaucoma or ocular hypertension;
-IOP =21 mmHg measured as the mean of two measurements in each eye;
-On treatment with IOP-lowering drugs for open-angle glaucoma for at least 24 weeks, or for ocular hypertension for at least 4 weeks;
-Best-corrected visual acuity =20 of 100 corresponding to logMAR of =0.7 at both eyes;
-In case of women; postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or using effective birth control (contraception) methods; Reliable contraception methods are considered the following:
•combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal
•progestogen-only hormonal contraception associated with inhibition of ovulation oral, implanable or injectable
•intrauterine device (IUD)
•intrauterine hormone-releasing system (IUS)
•bilateral tubal occlusion
•vasectomised partner
•sexual abstinence
-Expected by the investigator that IOP will remain controlled with the new treatment without optic nerve damage or progression of visual field loss;
-Able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits;
-Willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
-history of chronic or recurrent inflammatory eye disease, ocular trauma or infections;
-any uncontrolled systemic disease
-narrow-angle/angle-closure glaucoma;
-compromised cornea or corneal abnormalities that will preclude accurate IOP reading with an applanation tonometer
-clinically significant or progressive retinal disease;
-intraocular surgery within the past 6 months;
-ocular laser surgery within the past 3 months;
-best-corrected visual acuity worse than 0.7 logarithm of minimal angle of resolution (logMAR) score, extremely narrow or partially closed angle, cup/disk ratio >0.8;
-treatment with local or systemic corticosteroids in non-stable doses in the last 30 days;
-treatment with oral carbonic anhydrase inhibitors
-change in any systemic medication that could affect IOP (e.g. clonidine, b-blockers etc.) within 30 days before the beginning of the study;
- a history of severe hepatic, or renal impairment (creatinine clearance < 30 ml/min);
- a history of hyperchloraemic acidosis.
- known hypersensitivity to sulphonamides
-a history of allergic hypersensitivity or poor tolerance to any component of the eye drop solution used in this clinical trial;
-pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control;
-current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s);
-unwillingness or inability to comply with the clinical trial procedures;
-unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons;
-who are legally incapacitated;
-who are legally detained in an official institute.
Patients requiring bilateral IOP-reducing therapy are treated in both eyes, but only the eye that fulfils all of the inclusion criteria and none of the exclusion criteria will be the study eye. In case that both eyes fulfil all of the inclusion criteria and none of the exclusion criteria, then the Investigator has to select only one eye.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To confirm the clinical non-inferiority of Dorzo-Vision® sine Preservative-Free compared with the marketed Trusopt® Preservative-Free (PF) eye drops in patients with open angle glaucoma, or ocular hypertension, already on treatment with IOP-lowering drugs and low intraocular pressure (IOP=21 mmHg) by examining the change of diurnal IOP from end of study to baseline;Secondary Objective: The secondary objectives are<br> i) to compare the efficacy of the two dorzolamide products (test and reference) in terms of IOP and ii) to compare their safety profile (tolerability);Primary end point(s): Average diurnal IOP change from baseline to end of week 4.;Timepoint(s) of evaluation of this end point: At 4th week
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Averange change of diurnal IOP measured between baseline and week 2.<br>-Proportion of patients that kept the IOP =21 mmHg at the end of week 4.<br>-Proportion of withdrawals for therapeutic failure (diurnal IOP >21 mmHg) at any time point during or at the end of week 4;Timepoint(s) of evaluation of this end point: At 2nd week and any time during the study or at the end of 4th week