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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Unknown; Phase 4

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Preserved Bimatoprost 0.01%; Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02471105

S57304

Details and patient eligibility

About

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

Full 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.

Enrollment: 67 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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67 participants in 2 patient groups

Lumigan 0.01% + Saflutan 15 µg/ml

Experimental group

Description:

Bimatoprost 0.01 % Eye drops solution Topical use Once in the evening 3 months

Treatment:

Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml

Drug: Preserved Bimatoprost 0.01%

Saflutan 15 µg/ml + Lumigan 0.01%

Experimental group

Description:

Tafluprost Unit Dose Preservative Free 15microgram/ml Eye drops solution Topical use Once in the evening 3 months

Treatment:

Drug: Tafluprost Unit Dose Preservative Free 15microgram/ml

Drug: Preserved Bimatoprost 0.01%