Open Angle Glaucoma or Ocular Hypertension MedDRA version: 13.1 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Travoprost 0.004% eye drops solution
Product Code: Travoprost 0.004% eye drops solution
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Travoprost
CAS Number: 157283-68-6
O
Sponsors
Alfred E. Tiefenbacher (GmbH & Co. KG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria: - Informed consent signed by the subject - Male and female patients, aged 18 years or older - A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes - IOP controllable on one drug treatment in the study eye in a way that assures clinical stability of vision and the optic nerve throughout the study - Baseline IOP > 20 mmHg in the untreated study eye (in eyes not included in the study IOP must be controlled by either no pharmacological treatment, or by the study medicine or by initial therapy) at visit 2 - Best corrected visual acuity of 20/200 or better in the study eye 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: Main exclusion criteria: - Evidence in the subject's medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological or other significant acute or chronic abnormalities which might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the active agent under investigation - History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipients present in the pharmaceutical form of the investigational medicinal product - Acute infection or current ocular infection, i.e. conjunctivitis or keratitis - Chronic or recurrent inflammatory eye disease - Relevant ocular trauma within the past six months - Any abnormality preventing reliable applanation tonometry - Intraocular surgery or laser treatment within the past three months - Inability to discontinue contact lens wear during the study - Use of any systemic medication that would affect IOP with less than a 1-month stable dosing regimen before the screening visit as stated by the subject at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the equivalence of the topically administered Travoprost 0.004 % eye drops, solution (test formulation) compared to Travatan® 40 µg/ml Augentropfen (reference formulation) in lowering intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.;Secondary Objective: To assess the safety and tolerability of repeated topical administration of Travoprost 0.004 % eye drops, solution in subjects with open angle glaucoma or ocular hypertension.;Primary end point(s): The primary efficacy parameter will be the difference in IOP of the study eye from visit 1 (baseline) to day 42 ± 5 in each period: dIOP =IOP baseline – IOP travoprost | — |
Countries
Germany
Outcome results
None listed