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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471105
Recruitment Status : Unknown
Verified May 2016 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : June 15, 2015
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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

Condition or disease Intervention/treatment Phase
Ocular Hypertension Glaucoma Drug: Preserved Bimatoprost 0.01% Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : September 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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




Primary Outcome Measures :
  1. the difference in mean IOP values between the 2 groups [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. the difference in IOP values between the groups in change from baseline IOP [ Time Frame: month 3 and month 6 ]
  2. the difference in mean IOP between the 2 groups [ Time Frame: month 3 ]
  3. the difference in IOP between the 2 groups at each timepoints [ Time Frame: month 3 and month 6 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471105


Contacts
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Contact: Ingeborg Stalmans, Phd 003216332372 ingeborg.stalmans@uzleuven.be
Contact: Sien Boons 0032163340391 sien.boons@uzleuven.be

Locations
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Austria
Hommer Ophthalmology Institute Recruiting
Vienna, Austria
Contact: Anton Hommer         
Belgium
UZ Leuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Ingeborg Stalmans, Phd    003216332372    ingborg.stalmans@uzleuven.be   
Contact: Sien Boons, Optometrist    003216340391    sien.boons@uzleuven.be   
Italy
San Paolo Hospital Not yet recruiting
Milan, Italy
Contact: Luca Rossetti         
Bietti Foundation Not yet recruiting
Rome, Italy
Contact: francesco Oddone         
Switzerland
Clinical Research Centre Momorial A. de Rotschild Not yet recruiting
Geneve, Switzerland
Contact: Gordana Megevand         
United Kingdom
Gloucestershire Hospitals NHS Foundation Trust Not yet recruiting
Gloucestershire, United Kingdom
Contact: Andrew McNaught         
Western Eye Hospital Not yet recruiting
London, United Kingdom
Contact: Francesca Cordeiro         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Allergan
Investigators
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Principal Investigator: Ingeborg Stalmans, Phd UZ Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02471105    
Other Study ID Numbers: S57304
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Bimatoprost
Antihypertensive Agents