Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml
- Conditions
- Ocular HypertensionGlaucoma
- Interventions
- Registration Number
- NCT02471105
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 67
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lumigan 0.01% + Saflutan 15 µg/ml Preserved Bimatoprost 0.01% Bimatoprost 0.01 % Eye drops solution Topical use Once in the evening 3 months Saflutan 15 µg/ml + Lumigan 0.01% Tafluprost Unit Dose Preservative Free 15microgram/ml Tafluprost Unit Dose Preservative Free 15microgram/ml Eye drops solution Topical use Once in the evening 3 months Lumigan 0.01% + Saflutan 15 µg/ml Tafluprost Unit Dose Preservative Free 15microgram/ml Bimatoprost 0.01 % Eye drops solution Topical use Once in the evening 3 months Saflutan 15 µg/ml + Lumigan 0.01% Preserved Bimatoprost 0.01% Tafluprost Unit Dose Preservative Free 15microgram/ml Eye drops solution Topical use Once in the evening 3 months
- Primary Outcome Measures
Name Time Method the difference in mean IOP values between the 2 groups 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (7)
Clinical Research Centre Momorial A. de Rotschild
🇨🇭Geneve, Switzerland
Bietti Foundation
🇮🇹Rome, Italy
San Paolo Hospital
🇮🇹Milan, Italy
Hommer Ophthalmology Institute
🇦🇹Vienna, Austria
UZ Leuven
🇧🇪Leuven, Vlaams Brabant, Belgium
Western Eye Hospital
🇬🇧London, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
🇬🇧Gloucestershire, United Kingdom