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

NCT ID: NCT01975714

Last Updated: 2015-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Latanoprost (Period I) + Bimatoprost (Period II)

Preservative-free latanoprost 0.005% Unit Dose (LUDPF) (Monoprost) eye drops will be administered every day at 21:00 for the first 3 months.

After the follow-up visit, patient will start Preservative-free bimatoprost 0.03% Unit Dose (BUDPF) eye drops every day at 21:00 for the last 3 months.

Group Type: EXPERIMENTAL

Preservative-free latanoprost

Intervention Type: DRUG

Preservative-free bimatoprost

Intervention Type: DRUG

Bimatoprost (Period I) and Latanoprost (Period II)

Preservative-free bimatoprost 0.03% Unit Dose (LUDPF) (Monoprost) eye drops will be administered every day at 21:00 for the first 3 months.

After the follow-up visit, patient will start Preservative-free latanoprost 0.005% Unit Dose (BUDPF) eye drops every day at 21:00 for the last 3 months.

Group Type: EXPERIMENTAL

Preservative-free latanoprost

Intervention Type: DRUG

Preservative-free bimatoprost

Intervention Type: DRUG

Interventions

Preservative-free latanoprost

Intervention Type: DRUG

Preservative-free bimatoprost

Intervention Type: DRUG

Other Intervention Names

Monoprost

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Vision Institute Clinical Research Network

NETWORK

Sponsor Role: collaborator

Association for Innovation and Biomedical Research on Light and Image

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingeborg Stalmans, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

Vienna, , Austria

Leuven, , Belgium

Milan, , Italy

Rome, , Italy

Coimbra, , Portugal

Geneva, , Switzerland

London, , United Kingdom

Countries

Austria; Belgium; Italy; Portugal; Switzerland; United Kingdom

Other Identifiers

ECR-GLC-2013-06

Identifier Type: -

Identifier Source: org_study_id