Clinical trial NCT02471105: Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml
Official title: IOP and Tolerability Study of Preserved Bimatoprost 0.1% or Tafluprost Unit Dose Preservative Free 15microgram/ml, in Patients With OHT or Glaucoma Suitable for Prostaglandin Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ocular Hypertension
Glaucoma
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2015-06-15
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the difference in mean IOP values between the 2 groups
timeFrame: 6 months
Secondary outcomes:
measure: the difference in IOP values between the groups in change from baseline IOP
timeFrame: month 3 and month 6
measure: the difference in mean IOP between the 2 groups
timeFrame: month 3
measure: the difference in IOP between the 2 groups at each timepoints
timeFrame: month 3 and month 6
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hommer Ophthalmology Institute
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
city: Milan
country: Italy
facility: San Paolo Hospital
city: Rome
country: Italy
facility: Bietti Foundation
city: Geneve
country: Switzerland
facility: Clinical Research Centre Momorial A. de Rotschild
city: Gloucestershire
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Western Eye Hospital
Study officials:
affiliation: UZ Leuven
name: Ingeborg Stalmans, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lemmens S, Rossetti L, Oddone F, Sunaric-Megevand G, Hommer A, Vandewalle E, Francesca Cordeiro M, McNaught A, Montesano G, Stalmans I. Comparison of preserved bimatoprost 0.01% with preservative-free tafluprost: A randomised, investigator-masked, 3-month crossover, multicentre trial, SPORT II. Eur J Ophthalmol. 2021 Apr 5:11206721211006573. doi: 10.1177/11206721211006573. Online ahead of print.