Ocular Hypertension (IOP>22 mmHg), Primary Open Angle Glaucoma (mean defect between 0 and -12 db in a visual field) MedDRA version: 9.1 Level: LLT Classification code 10030043 Term: Ocular hypertension MedDRA version: 9.1 Level: LLT Classification code 10036719 Term: Primary open angle glaucoma
Conditions
Interventions
Product Name: Latanoprost
Product Code: Not Applicable
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: LATANOPROST
CAS Number: 130209824
Current Sponsor code: latanoprost
Concentration u
Sponsors
RDR Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • written informed consent • male and female patients with unilateral or bilateral OH (defined by an IOP > 22 mmHg at several measurements) or POAG at an early stage (defined by a mean defect between 0 and -12 db in a visual field performed with an automated perimeter within the 3 months before the study) • age = 18 years • with at least in one eye, IOP above or equal 22 mmHg at 8 am and below or equal 30 mmHg at 8 am, 12 noon and 4 pm under one of the following conditions: - patients with untreated OHT or - patients completing the 4-week washout period of an initial monotherapy with a prostaglandin or beta-blocker • patients whose initial therapy requires a washout may, upon decision of the investigator, be treated within this period by dorzolamide or a miotic, which will be stopped 1 week or 3 days, respectively, before study treatment initiation • best corrected visual acuity = 20/100 (Snellen) or 2/10 (Monoyer) • female subjects must be using a medically accepted form of birth control and must have a negative urine pregnancy test at screening • able to provide informed consent after risks and benefits of the study have been explained • ability to communicate effectively with study personnel. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • in both eyes, IOP 30 mmHg at 8 a.m. or 12 noon or 4 p.m. • known sensitivity to latanoprost or any component of the drug products • use of contact lenses; • previous or active corneal disease; • monophthalmia; • history of macular oedema; • any intraocular infection or inflammation within the previous 3 months; • ocular surgery or severe trauma within the previous 3 months; • intraocular laser therapy within the last 3 months; • angle closure, congenital and secondary glaucoma (including pigmentary glaucoma); • ocular corticosteroids; • need of any other topical or systemic treatment of OH or POAG; • pregnancy or breastfeeding; • severe dysfunction of the liver or the kidneys; • active wasting disease including cancer; • angina pectoris not controlled by medical or surgical treatment; • severe asthma bronchiale (FEV1 < 70% of predicted value); • haematological diseases such as aplastic anaemia, pancytopenia, or haemolytic icterus; • current or anamnestic drug addiction or extensive alcohol use; • participation in another clinical study within 4 weeks prior to enrolment; • history of non-compliance; • any condition that compromises the ability to understand or comply with study requirements; • committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine that the effectiveness and tolerability of Latanoprost RDR 0.005% Eye Drops Test Formulation is not inferior to Xalatan 0.005% Eye Drops.;Secondary Objective: Not Applicable;Primary end point(s): The primary end point for the evaluation of the efficacy shall be the mean change of 8 a.m. IOP measured on the study eye from the baseline value to the end of the trial. | — |
Countries
Bulgaria, Germany, Latvia, Lithuania
Outcome results
None listed