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

Glaucoma Clinical Trial

— SPORT  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975714
• Other study ID #: ECR-GLC-2013-06
• Status: Completed
• Phase: Phase 4
• First received: October 23, 2013
• Last updated: October 28, 2015
• Start date: October 2013
• Est. completion date: February 2015

Study information

• Verified date: October 2015
• Source: Association for Innovation and Biomedical Research on Light and Image
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHPItaly: The Italian Medicines AgencyPortugal: National Pharmacy and Medicines InstituteSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 84 Years

Eligibility

Inclusion Criteria includes:

• Ocular hypertension, pseudoexfoliation glaucoma (XFG) or primary open-angle glaucoma (POAG) patients that have been on a preserved prostaglandin monotherapy for at least 6 weeks. At prescreening and screening visit the IOP is less than or equal to 21 mm Hg in both eyes.

Exclusion Criteria includes:

• Any ocular condition that are of safety concern, visual field defects with an MD value above -12dB, a closed/barely open anterior chamber angles or history of acute angle closure on either eye, ocular surgery 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 pretrial visit on either eye, pigmentary glaucoma or neovascular glaucoma on either eye, topical ocular medication that can interfere with study medication on either eye and known hypersensitivity to any component of the trial drug solutions and participation in any other clinical trial, involving an investigational drug within one month prior to pretrial visit

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
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Preservative-free latanoprost

• Preservative-free bimatoprost

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Association for Innovation and Biomedical Research on Light and Image	European Vision Institute Clinical Research Network

Countries where clinical trial is conducted

Austria,  Belgium,  Italy,  Portugal,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in mean IOP values between the 2 groups at 6 months		6 months	No
Secondary	Difference in IOP values IOP values, visual acuity, hyperaemia, visual acuity and tolerability between the groups in change from baseline		Month 3; Month 6	Yes