Ocular hypertension and glaucoma MedDRA version: 17.1 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 17.1 Level: PT Classification code 10018304 Term: Glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Preservatived Bimatoprost, Lumigan 0.1 mg/ml
Pharmaceutical Form: Eye drops, solution
Trade Name: Tafluprost Unit Dose Preservative Free
Pharmaceutical Form: Eye drops, suspension in si
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • A patient suffering from ocular hypertension, XFG or POAG and needs treatment in both eyes • At screening visit (09:00 ± 1 hr) the IOP is less than or equal to 21 mm Hg in both eyes. • Patient is older than 39 years and younger than 85 years • Patient is able and willing to participate in the study for the whole duration of the follow up and is willing to sign the consent form. 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 37
Exclusion criteria
Exclusion criteria: • Unwilling to sign informed consent; • Not at least 40 years old; • Ocular condition that are of safety concern and that can interfere with the study results; • Visual field defects with an MD value above -15dB on either eye • Contact lens wearer; • Closed/barely open anterior chamber angles or history of acute angle closure on either eye as assessed by gonioscopy; • Ocular surgery (other than glaucoma surgery) or argon laser trabeculoplasty within the past three months on either eye; • Glaucoma surgery within the past 6 months on either eye; • Ocular inflammation/infection occurring within three months prior to pre-trial visit on either eye; • Concomitant topical ocular medication that can interfere with study medication on either eye; • Known hypersensitivity to any component of the trial drug solutions; • Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement; • Refractive surgery patients at any time; • Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing; • Inability to adhere to treatment/visit plan; • Have participated in any other Interventional clinical trial (i.e., requiring informed consent) involving an investigational drug within one month prior to pre-trial visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the difference in mean IOP values between the2 grôups at 6 months. ;Secondary Objective: The secondary opbjectives includes a comparison of change from baseline IOP between the treatment groups at month 3 and month 6, a comparison of mean IOP at month 3, a comparison of the result at each timepoint at month 3 and 6, as well as a comparison of tolerability and adverse event. ;Primary end point(s): The primary endpoint will be the difference in mean IOP values between the 2 groups at 6 months;Timepoint(s) of evaluation of this end point: month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • the difference in IOP values between the groups in change from baseline IOP at month 3 and month 6 respectively; • the difference in mean IOP between the 2 groups at 3 months; • the difference in IOP between the 2 groups at each timepoints at months 3 and 6; • Safety endpoints will be; visual acuity, adverse events, slit lamp biomicroscopy, ocular tolerability and optic nerve assessment. ;Timepoint(s) of evaluation of this end point: month 6 | — |
Countries
Belgium, Switzerland
Contacts
Public ContactIngeborg Stalmans
UZ LEuven
Outcome results
None listed