The effect of AZARGA(R) on the central and spacial-temporal contrast sensitivity of patients with normal tension glaucoma will be examined. Healthy controls are required to prove the disease specific effect of the trial drug. MedDRA version: 12.1 Level: LLT Classification code 10019279 Term: Heart failure MedDRA version: 12.1 Level: LLT Classification code 10003555 Term: Asthma bronchial MedDRA version: 12.1 Level: LLT Classification code 10021005 Term: Hypoglycemia MedDRA version: 12.1 Leve
Conditions
Sponsors
University Erlangen-Nuremberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: OVERALL ? Patients from the clinic and outpatient clinic of Ophthalmology, Erlangen ? Age 18 to 75 years ? Both sexes (10 ± 1 male or female subjects, respectively, each per group) ? Ability to sign an informed consent GROUP OF GLAUCOMA ? 20 patients with normal tension glaucoma (untreated intraocular pressur 2 dB and/or ? Spatial-temporal contrast sensitivity = 5 (Score according to Patel) and/or ? Reduced peripapillary mean retinal nerve fiber layer thickness (Heidelberg Retinatomography, =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Glaucoma of other origin (e.g. angle closure glaucoma, pseudoexfoliative glaucoma, pigmentary glaucoma) ? Other eye diseases involving the retina and visual pathway ? Functional monophthalmia ? Preexisting damage of the cornea ? Use of contact lenses ? Ametropia > ±4,0 dpt sph and > ±2,0 dpt cyl ? History of heart failure, cardiogenic shock, , Prinzmetal angina, arterial hypotension, sinus bradycardia, av block II° and III° ? Asthma bronchiale, severe COPD, bronchial hyperreactivity ? Severe hepatic or renal impairment (creatinine clearance <30 ml/min) ? Diabetes mellitus, affinity to spontanous hypoglycemia ? Severe anaphylactic reaction in history ? Hyperchloremic acidosis, hyperthyreosis ? Hypersensitivity to beta-adrenergic blocking agents or sulfonamides ? Pregnancy, lactation period ? Application of oral calcium channel blocker, guanethidine, antarrhythmic agents, digitalis glycosides, parasympathicomimetics, clonidine, CYP2D6 inhibitors [quinidine, cimetidine], antidiabetics, beta-adrenergic blockers or inhibitors of carbonic anhydrase ? Participation in another clinical trial within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to examine if lowering of the intraocular pressure by combined local application of timolol/ brinzolamide improves the spacial-temporal contrast sensitivity of patients with normal tension glaucoma.;Secondary Objective: By testing the retinal sensitivity to distinguish light stimuli and the subjective contrast sensitivity with and without photostress, it is possible to determine, whether in glaucoma predominantly the magno-cellular or the parvo-cellular sytem of the retinal ganglion cells is sensitive to the treatment.;Primary end point(s): The Freiburger Vision Test "FrACT" will be implemented for examination. The therapy will be considered effective, if in the glaucoma group the time of readaption after photo stress and the threshold of contrast sensitivity changes significantly (p = 0,05) after treatment. | — |
Countries
Germany
Outcome results
None listed