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

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

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

Study Overview

• Status: Unknown
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: Preserved Bimatoprost 0.01%; Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml

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.

• Study Type: Interventional
• Enrollment (Anticipated): 67
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ingeborg Stalmans, Phd; Phone Number: 003216332372; Email: ingeborg.stalmans@uzleuven.be
• Study Contact Backup: Name: Sien Boons; Phone Number: 0032163340391; Email: sien.boons@uzleuven.be

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Hommer Ophthalmology Institute
    • Contact: Anton Hommer
• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
      • Contact: Ingeborg Stalmans, Phd; Phone Number: 003216332372; Email: ingborg.stalmans@uzleuven.be
      • Contact: Sien Boons, Optometrist; Phone Number: 003216340391; Email: sien.boons@uzleuven.be
• Italy
  • Milan, Italy
    • Not yet recruiting
    • San Paolo Hospital
    • Contact: Luca Rossetti
  • Rome, Italy
    • Not yet recruiting
    • Bietti Foundation
    • Contact: francesco Oddone
• Switzerland
  • Geneve, Switzerland
    • Not yet recruiting
    • Clinical Research Centre Momorial A. de Rotschild
    • Contact: Gordana Megevand
• United Kingdom
  • Gloucestershire, United Kingdom
    • Not yet recruiting
    • Gloucestershire Hospitals NHS Foundation Trust
    • Contact: Andrew McNaught
  • London, United Kingdom
    • Not yet recruiting
    • Western Eye Hospital
    • Contact: Francesca Cordeiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumigan 0.01% + Saflutan 15 µg/ml; Bimatoprost 0.01 % Eye drops solution Topical use Once in the evening 3 months	Drug: Preserved Bimatoprost 0.01%; Eye drops solution Topical use Once in the evening 3 months; Other Names: BIMMD; Lumigan 0.01 %; Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml; Eye drops solution Topical use Once in the evening 3 months; Other Names: TUDPF; Saflutan
Experimental: Saflutan 15 µg/ml + Lumigan 0.01%; Tafluprost Unit Dose Preservative Free 15microgram/ml Eye drops solution Topical use Once in the evening 3 months	Drug: Preserved Bimatoprost 0.01%; Eye drops solution Topical use Once in the evening 3 months; Other Names: BIMMD; Lumigan 0.01 %; Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml; Eye drops solution Topical use Once in the evening 3 months; Other Names: TUDPF; Saflutan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the difference in mean IOP values between the 2 groups	6 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Allergan
• Investigators: Principal Investigator: Ingeborg Stalmans, Phd, UZ Leuven

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: June 12, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: S57304