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

NCT01975714 | Completed Phase 4

• 1 other identifier: ECR-GLC-2013-06
• Study Type: interventional
• Target: 67
• Locations: 6 countries
• Sites: 7

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

Keywords

Glaucoma; Ocular hypertension; Preservative-free prostaglandins

Outcome Measures

Primary Outcomes (1)

• Difference in mean IOP values between the 2 groups at 6 months

  6 months

Secondary Outcomes (1)

• Difference in IOP values IOP values, visual acuity, hyperaemia, visual acuity and tolerability between the groups in change from baseline

  Month 3; Month 6

Study Arms (2)

Latanoprost (Period I) + Bimatoprost (Period II)

EXPERIMENTAL

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.

Drug: Preservative-free latanoprost; Drug: Preservative-free bimatoprost

Bimatoprost (Period I) and Latanoprost (Period II)

EXPERIMENTAL

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.

Drug: Preservative-free latanoprost; Drug: Preservative-free bimatoprost

Interventions

Preservative-free latanoprost DRUG

Also known as: Monoprost

Bimatoprost (Period I) and Latanoprost (Period II); Latanoprost (Period I) + Bimatoprost (Period II)

Preservative-free bimatoprost DRUG

Bimatoprost (Period I) and Latanoprost (Period II); Latanoprost (Period I) + Bimatoprost (Period II)

Eligibility Criteria

• Age: 40 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Association for Innovation and Biomedical Research on Light and Image: lead
• European Vision Institute Clinical Research Network: collaborator

Study Sites (7)

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Rome, Italy

Location

Unknown Facility

Coimbra, Portugal

Location

Unknown Facility

Geneva, Switzerland

Location

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Ingeborg Stalmans, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: November 5, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

BE (1); IT (2); AU (1); PT (1); CH (1); GB (1)