Intraocular pressure and tolerability Study of Preservative Free Bimatoprost 0.03% Unit Dose (BUDPF) or preservative free Latanoprost 0.005% Unit Dose (LUDPF) (Monoprost®) in patients with Ocular hypertension or glaucoma: A Randomized, single masked, 3 month cross-over, Investigator led, European multicentre Trial (SPORT)

Conditions: Ocular hypertension and glaucoma.
MedDRA version: 14.1Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 14.1Level: PTClassification code 10018304Term: GlaucomaSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2013-003490-10-PT

Lead Sponsor: AIBILI (EVICR.net)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 67

Inclusion Criteria

- A patient suffering from ocular hypertension, XFG or POAG that has been on a preserved prostaglandin monotherapy for at least 6 weeks and needs treatment in both eyes
- At pre-screening and screening visit (09:00 ± 1 hr) the IOP is less than or equal to 21 mm Hg in both eyes.
- Patient is older than 39 years and younger than 85 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37

Exclusion Criteria

- Unwilling to sign informed consent;
- Not at least 40 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 -12dB with Humphey or above +12dB with Octopus on either eye;
- 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;
- Patients with pigmentary glaucoma on either eye;
- Patients with Neovascular glaucoma 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 clinical trial (i.e., requiring informed consent) involving an investigational drug within one month prior to pre-trial visit.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to compare the difference in mean Intraocular pressure values between the 2 groups at 6 months.;Secondary Objective: The secondary objectives includes a comparison of change of Intraocular pressure, IOP, from baseline between the treatment groups at month 3 and month 6, a comparison of mean IOP at month 3, a comparison of the result at each timepoint at month 3 and 6, as well as a comparison of tolerability and adverse events. A comparison of change from screening visit IOP after repeated dose administration of BUDPF or the LUDPF at month 3 and month 6 will also be performed.;Primary end point(s): The primary outcome will be the difference in mean IOP values between the 2 groups at 6 months;Timepoint(s) of evaluation of this end point: Month 6

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - the difference in IOP values between the groups in change from baseline IOP at month 3 and month 6 respectively;<br>- the difference in IOP values between the groups in change from screening visit IOP, at month 3 and month 6 respectively;<br>- the difference in mean IOP between the 2 groups at 3 months;<br>- the difference in IOP between the 2 groups at each timepoints at months 3 and 6;<br>- safety endpoints includes visual acuity, adverse events, slit lamp biomicroscopy, ocular tolerability and optic nerve assessment;<br>;Timepoint(s) of evaluation of this end point: - the difference in IOP values between the groups in change from baseline IOP at month 3 and month 6;<br>- the difference in IOP values between the groups in change from screening visit IOP, at month 3 and month 6;<br>- the difference in mean IOP between the 2 groups at 3 months;<br>- the difference in IOP between the 2 groups at each timepoints at months 3 and 6;