glaucoma and ocular hypertension MedDRA version: 20.0 Level: LLT Classification code 10036719 Term: Primary open angle glaucoma System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Travatan
Product Name: Travatan
Pharmaceutical Form: Eye drops
INN or Proposed INN: Travoprost
Other descriptive name: TRAVOPROST
Concentration unit: µg/ml microgram(s)/millilitre
Concentr
Sponsors
Department of Ophthalmology, Rigshospitalet-Glostrup
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Age >18years b. Danish speaking c. Open angle glaucoma or ocular hypertension d. Average intraocular pressure equal to or above 22 mmHg based on 3 measurements on each 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: a. history of significant eye diseae (including okular trauma) other than open angle glaucoma and ocular hypertension b. Pressure difference equal to or above 4 mmHg between eyes c. corneal thickness 600µm d. treatment with steroids within the last 3 months from inclusion e. Significant untreated systemic disease such as hypertension, heart failure, diabetes mellitus, stroke, lung disease and autoimmune diseases. Diseases are not reason for exclusion if they are well treated or does not need treatment f. smoker at inclusion g. pregnant or breast feeding h. women using unsafe anticonception i. allergy towards trial medication j. patients who cannot cooperate in eye examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare goblet cell density when treating with a differently preserved travoprost eye drops in each eye;Secondary Objective: To compare eye pressure, ocular surface, tear film and symptoms of dry eyes when treating with a differently preserved travoprost eye drops in each eye;Primary end point(s): Goblet cell density E.5.1.1;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Intraocular pressure lowering effect Corneal and conjunctival surface Mucin in tear film Symptoms of dry eyes;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Information
Department of Drug Design and Pharmacology, University of Copenhagen
Outcome results
None listed