NCT01975714

Intraocular Pressure and Tolerability Study of Preservative-free Prostaglandins (Bimatoprost and Latanoprost) on Glaucoma and Ocular Hypertension: European, Multicentric, Investigator-led, Single Masked Study

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Association for Innovation and Biomedical Research on Light and Image · Academic / Other
• Sex: All
• Age: 40 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

Bimatoprost 0.03% preservative free monodose eye drops solution (BUDPF) is a new product composed of a synthetic prostamide, bimatoprost 0.3% in a preservative free formulation. This new product is used as a once-daily topical ocular therapy for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma, or ocular hypertension, and that are sensitive to preservatives. The individual active component of BUDPF, bimatoprost is an established therapeutic agent with well documented IOP efficacy (1). Prostamides, such as bimatoprost, are believed to lower IOP mainly by increasing uveoscleral outflow. The comparator, Preservative Free Latanoprost 0.005% Unit Dose (LUDPF, eg. Monoprost®), was recently launched in a number of countries in Europe and contains latanoprost in a new preservative free formulation. It is clinically important to compare these newly entered preservative free products with respect to tolerability and efficacy. A better tolerability combined with maximum efficacy will reduce the burden of daily glaucoma therapy and provide a clear therapeutic benefit to the glaucoma patient by providing enhanced compliance and real-world IOP-lowering efficacy. The hypothesis of the study is that monodose bimatoprost is more effective than monodose latanoprost by at least 1 mmHg. (AIBILI applied for an unrestricted grant from Allergan to perform this study)

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Preservative-free latanoprost
DRUG	Preservative-free bimatoprost

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-11-05
• Last updated: 2015-10-29

Locations

7 sites across 6 countries: Austria, Belgium, Italy, Portugal, Switzerland, United Kingdom