glaucoma and ocular hypertension MedDRA version: 19.1 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Monopost
Pharmaceutical Form: Eye drops, solution in single-dose container
INN or Proposed INN: Latanoprost
Other descriptive name: LATANOPROST
Concentration unit: µg/ml microgram(s)/milli
Sponsors
Medical University of Vienna, Department of Clinical Pharmacology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men and women aged over 18 years - Diagnosed primary open angle glaucoma treated with prostaglandin analogues containing preservatives for at least 2 months. OR - Patients with ocular hypertension treated with prostaglandin analogues containing preservatives for at least 2 months - IOP = 21 mmHg in the study eye at the screening examination (under treatment) - Mean TFT at the screening visit =65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: - Participation in a clinical trial in the 3 weeks before the screening visit - Severe visual field loss as defined as an MD of -15 or worse in the study eye - Symptoms of a clinically relevant illness in the 3 weeks before the first study day - Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator - Sjögren’s syndrome - Stevens-Johnson syndrome - Presence or history of a severe ocular condition that will interfere with the study aim as judged by the clinical investigator - Presence or history of allergic conjunctivitis - Treatment with corticosteroids in the 4 weeks preceding the study - Wearing of contact lenses - Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except glaucoma medication or topical lubricants - Ocular infection - Ocular surgery in the 6 months preceding the study (except laser trabeculoplasty) - Pregnancy, planned pregnancy or lactating - Contraindicaton against the use of topical prostaglandin therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To study the effect of randomizing glaucoma or ocular hypertension patients who are on preserved prostaglandin formulations to either preservative free latanoprost or preserved latanoprost on other signs and symptoms of ocular surface disease, as well as on intraocular pressure.;Primary end point(s): The primary outcome will be the difference in mean tear film thickness values between the 2 groups at 6 months;Timepoint(s) of evaluation of this end point: Month 1, 3 and 6;Main Objective: To study the effect of randomizing glaucoma or ocular hypertension patients who are on preserved prostaglandin formulations to either preservative free latanoprost or preserved latanoprost on tear film thickness. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcome will be the difference in signs and symptoms of ocular surface disease and intraocular pressure between the 2 groups at 6 months;Timepoint(s) of evaluation of this end point: Month 1, 3 and 6 | — |
Countries
Austria
Contacts
Public ContactDepartment of Clinical Pharmacology
Medical University of Vienna
Outcome results
None listed