Glaucoma MedDRA version: 20.0 Level: LLT Classification code 10037118 Term: Pseudoexfoliation glaucoma System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Taflotan
Pharmaceutical Form: Eye drops, solution in single-dose container
INN or Proposed INN: tafluprost
Other descriptive name: TAFLUPROST
Sponsors
Mika Harju
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: age of 50 –100 years, possibility to attend period of 12 months, exfoliation, newly diagnosed exfoliation glaucoma by EGS (European glaucoma society) guidelines or ocular hypertensio TA 24 mmHg or more, eye pressure less than 35 mmHg. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 82
Exclusion criteria
Exclusion criteria: Exclusion criteria: advanced glaucoma, target IOP less than 15, starting eye pressure 35 or more, eye vision 0.2 or worse, angle closure, unable to use eye drops, significant cataract, other active eye disease, previous intraocular operation excluding uncomplicated cataract surgery 1 year ago or earlier, clinical significant macular edema, intraocular injections to wet AMD, proliferative diabetic retinopathy, intraocular tumor, IOL luxation, active uveitis, serious other medical condition, participating in other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to show the equilance in efficacy of SLT laser treatment compared to medical therapy as a primary therapy in exfoliation glaucoma.;Secondary Objective: Not applicable;Primary end point(s): Primary end point is enhancement of treatment by adding eye drops. ;Timepoint(s) of evaluation of this end point: 12 months from the beginning of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points are eye dryness and eye pressure and long term end points are cumulative success of SLT-treatment and need for glaucoma surgery.;Timepoint(s) of evaluation of this end point: 12 months and long term evaluation up to 10 years. | — |
Countries
Finland
Contacts
Public ContactEye hospital
Helsinki University Eye and Ear Hospital
Outcome results
None listed