Glaucoma, Ocular Hypertension
Conditions
Brief summary
This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a clinical setting.
Detailed description
* A prospective, randomized, investigator-masked, crossover comparison; * Ocular hypertension or glaucoma (XFG or POAG) patients and who consent to participate will be enrolled in this study * Patients will be scheduled for a screening visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (±1 hour). * Patients who are on therapy at the screening visit and who consent to participate will undergo a washout period for 4 weeks (depending on therapy) before the baseline visit; * Patient can under the washout period be given brinzolamide (Azopt) if needed, Azopt should then be discontinued 5 days before baseline visit; * After the screening visit (and after wash-outperiod for treated patients) patients will be scheduled to undergo a baseline visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (± 1 hour with a minimum of 3 hours between readings) and will then be randomized for Period 1 to receive either BIMMD drops once in the evening (20:30) or TUDPF drops once in the evening (20:30) for 3 month * After 3 month, patients will be switched for Period 2, to the opposite treatment (e.g. switched to either BIMMD or TUDPF) to be dosed in the evening; * After another 3 months they will undergo the final evaluation of IOP levels and of tolerability; * Intermediate safety visits may be scheduled at the discretion of the investigator.
Interventions
DRUGPreserved Bimatoprost 0.01%
Eye drops solution Topical use Once in the evening 3 months
DRUGTafluprost Unit Dose Preservative Free 15microgram/ml
Eye drops solution Topical use Once in the evening 3 months
Sponsors
Allergan
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A patient suffering from ocular hypertension, XFG or POAG and needs treatment in both eyes * Patient is at least 18 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.
Exclusion criteria
* Unwilling to sign informed consent; * Younger than 18 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 on Humphrey (or the equivalent in Octopus) and/or threatening fixation * 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. * History of COPD, asthma or heart failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the difference in mean IOP values between the 2 groups | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| the difference in IOP values between the groups in change from baseline IOP | month 3 and month 6 |
| the difference in mean IOP between the 2 groups | month 3 |
| the difference in IOP between the 2 groups at each timepoints | month 3 and month 6 |
Countries
Austria, Belgium, Italy, Switzerland, United Kingdom
Contacts
Primary ContactIngeborg Stalmans, Phd
Backup ContactSien Boons
Outcome results
None listed