SPORTII: Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml
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 |
---|---|---|
|
Phase 4 |
Detailed Description
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A prospective, randomized, investigator-masked, crossover comparison;
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Ocular hypertension or glaucoma (XFG or POAG) patients and who consent to participate will be enrolled in this study
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Patients will be scheduled for a screening visit IOP assessment (IOP measurements at 08:30, 12:30 and 16:30 (±1 hour).
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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;
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Patient can under the washout period be given brinzolamide (Azopt) if needed, Azopt should then be discontinued 5 days before baseline visit;
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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
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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;
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After another 3 months they will undergo the final evaluation of IOP levels and of tolerability;
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Intermediate safety visits may be scheduled at the discretion of the investigator.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml
Eye drops solution Topical use Once in the evening 3 months
Other Names:
|
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:
Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml
Eye drops solution Topical use Once in the evening 3 months
Other Names:
|
Outcome Measures
Primary Outcome Measures
- the difference in mean IOP values between the 2 groups [6 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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A patient suffering from ocular hypertension, XFG or POAG and needs treatment in both eyes
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Patient is at least 18 years
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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:
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Unwilling to sign informed consent;
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Younger than 18 years old;
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Ocular condition that are of safety concern and that can interfere with the study results;
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Visual field defects with an MD value above -15dB on either eye on Humphrey (or the equivalent in Octopus) and/or threatening fixation
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Contact lens wearer;
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Closed/barely open anterior chamber angles or history of acute angle closure on either eye as assessed by gonioscopy;
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Ocular surgery (other than glaucoma surgery) or argon laser trabeculoplasty within the past three months on either eye;
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Glaucoma surgery within the past 6 months on either eye;
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Ocular inflammation/infection occurring within three months prior to pre-trial visit on either eye;
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Concomitant topical ocular medication that can interfere with study medication on either eye;
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Known hypersensitivity to any component of the trial drug solutions;
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Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement;
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Refractive surgery patients at any time;
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Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing;
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Inability to adhere to treatment/visit plan;
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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.
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History of COPD, asthma or heart failure
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- S57304