Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml

Glaucoma Clinical Trial

— SPORTII  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02471105
• Other study ID #: S57304
• Status: Recruiting
• Phase: Phase 4
• First received: March 31, 2015
• Last updated: May 11, 2016
• Start date: September 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Ingeborg Stalmans, Phd
• Phone: 003216332372
• Email: ingeborg.stalmans[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This cross-over study will investigate the efficacy and safety of BIMMD and TUDPF in a clinical setting.

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 information / eligibility

• Status: Recruiting
• Enrollment: 67
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• Preserved Bimatoprost 0.01%
Eye drops solution Topical use Once in the evening 3 months
• Tafluprost Unit Dose Preservative Free 15microgram/ml
Eye drops solution Topical use Once in the evening 3 months

Locations

Country	Name	City	State
Austria	Hommer Ophthalmology Institute	Vienna
Belgium	UZ Leuven	Leuven	Vlaams Brabant
Italy	San Paolo Hospital	Milan
Italy	Bietti Foundation	Rome
Switzerland	Clinical Research Centre Momorial A. de Rotschild	Geneve
United Kingdom	Gloucestershire Hospitals NHS Foundation Trust	Gloucestershire
United Kingdom	Western Eye Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Allergan

Countries where clinical trial is conducted

Austria,  Belgium,  Italy,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the difference in mean IOP values between the 2 groups		6 months	No
Secondary	the difference in IOP values between the groups in change from baseline IOP		month 3 and month 6	No
Secondary	the difference in mean IOP between the 2 groups		month 3	No
Secondary	the difference in IOP between the 2 groups at each timepoints		month 3 and month 6	No