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

Glaucoma Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

• NCT number: NCT02471105
• Study type: Interventional
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Ingeborg Stalmans, Phd
• Phone: 003216332372
• Email: ingeborg.stalmans@uzleuven.be
• Status: Recruiting
• Phase: Phase 4
• Start date: September 2015
• Completion date: December 2017