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

Primary Purpose

Ocular Hypertension, Glaucoma

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Preserved Bimatoprost 0.01%
Tafluprost Unit Dose Preservative Free 15microgram/ml
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hommer Ophthalmology InstituteRecruiting
  • UZ LeuvenRecruiting
  • San Paolo Hospital
  • Bietti Foundation
  • Clinical Research Centre Momorial A. de Rotschild
  • Gloucestershire Hospitals NHS Foundation Trust
  • Western Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lumigan 0.01% + Saflutan 15 µg/ml

Saflutan 15 µg/ml + Lumigan 0.01%

Arm Description

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

Outcomes

Primary Outcome Measures

the difference in mean IOP values between the 2 groups

Secondary Outcome Measures

the difference in IOP values between the groups in change from baseline IOP
the difference in mean IOP between the 2 groups
the difference in IOP between the 2 groups at each timepoints

Full Information

First Posted
March 31, 2015
Last Updated
May 11, 2016
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02471105
Brief Title
Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumigan 0.01% + Saflutan 15 µg/ml
Arm Type
Experimental
Arm Description
Bimatoprost 0.01 % Eye drops solution Topical use Once in the evening 3 months
Arm Title
Saflutan 15 µg/ml + Lumigan 0.01%
Arm Type
Experimental
Arm Description
Tafluprost Unit Dose Preservative Free 15microgram/ml Eye drops solution Topical use Once in the evening 3 months
Intervention Type
Drug
Intervention Name(s)
Preserved Bimatoprost 0.01%
Other Intervention Name(s)
BIMMD, Lumigan 0.01 %
Intervention Description
Eye drops solution Topical use Once in the evening 3 months
Intervention Type
Drug
Intervention Name(s)
Tafluprost Unit Dose Preservative Free 15microgram/ml
Other Intervention Name(s)
TUDPF, Saflutan
Intervention Description
Eye drops solution Topical use Once in the evening 3 months
Primary Outcome Measure Information:
Title
the difference in mean IOP values between the 2 groups
Time Frame
6 months
Secondary Outcome Measure Information:
Title
the difference in IOP values between the groups in change from baseline IOP
Time Frame
month 3 and month 6
Title
the difference in mean IOP between the 2 groups
Time Frame
month 3
Title
the difference in IOP between the 2 groups at each timepoints
Time Frame
month 3 and month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingeborg Stalmans, Phd
Phone
003216332372
Email
ingeborg.stalmans@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Sien Boons
Phone
0032163340391
Email
sien.boons@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingeborg Stalmans, Phd
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hommer Ophthalmology Institute
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anton Hommer
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingeborg Stalmans, Phd
Phone
003216332372
Email
ingborg.stalmans@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Sien Boons, Optometrist
Phone
003216340391
Email
sien.boons@uzleuven.be
Facility Name
San Paolo Hospital
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Rossetti
Facility Name
Bietti Foundation
City
Rome
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
francesco Oddone
Facility Name
Clinical Research Centre Momorial A. de Rotschild
City
Geneve
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gordana Megevand
Facility Name
Gloucestershire Hospitals NHS Foundation Trust
City
Gloucestershire
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew McNaught
Facility Name
Western Eye Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Cordeiro

12. IPD Sharing Statement

Citations:
PubMed Identifier
33818170
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.
Results Reference
derived

Learn more about this trial

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

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