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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Ocular Hypertension, Glaucoma

Intervention / Treatment
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* Drug: Preserved Bimatoprost 0.01%
* Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumigan 0.01% + Saflutan 15 µg/ml<br>Bimatoprost 0.01 % Eye drops solution Topical use Once in the evening 3 months | Drug: Preserved Bimatoprost 0.01%<br>* Eye drops solution Topical use Once in the evening 3 months<br>* Other names: Lumigan 0.01 %;Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml<br>* Eye drops solution Topical use Once in the evening 3 months<br>* Other names: Saflutan;|
| Experimental: Saflutan 15 µg/ml + Lumigan 0.01%<br>Tafluprost Unit Dose Preservative Free 15microgram/ml Eye drops solution Topical use Once in the evening 3 months | Drug: Preserved Bimatoprost 0.01%<br>* Eye drops solution Topical use Once in the evening 3 months<br>* Other names: Lumigan 0.01 %;Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml<br>* Eye drops solution Topical use Once in the evening 3 months<br>* Other names: Saflutan;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |