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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT02471105
Collaborator
Allergan (Industry)
67
7
2
27
9.6
0.4

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 1, 2015
Anticipated Primary Completion Date :
May 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. the difference in mean IOP values between the 2 groups [6 months]

    Secondary Outcome Measures

    1. the difference in IOP values between the groups in change from baseline IOP [month 3 and month 6]

    2. the difference in mean IOP between the 2 groups [month 3]

    3. the difference in IOP between the 2 groups at each timepoints [month 3 and month 6]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hommer Ophthalmology Institute Vienna Austria
    2 UZ Leuven Leuven Vlaams Brabant Belgium 3000
    3 San Paolo Hospital Milan Italy
    4 Bietti Foundation Rome Italy
    5 Clinical Research Centre Momorial A. de Rotschild Geneve Switzerland
    6 Gloucestershire Hospitals NHS Foundation Trust Gloucestershire United Kingdom
    7 Western Eye Hospital London United Kingdom

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven
    • Allergan

    Investigators

    • Principal Investigator: Ingeborg Stalmans, Phd, UZ Leuven

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT02471105
    Other Study ID Numbers:
    • S57304
    First Posted:
    Jun 15, 2015
    Last Update Posted:
    May 12, 2016
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 12, 2016