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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2015-10-29

No results posted yet for this study

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

Interventions

DRUG

Preservative-free latanoprost

DRUG

Preservative-free bimatoprost

Sponsors & Collaborators

  • European Vision Institute Clinical Research Network

    collaborator NETWORK

  • Association for Innovation and Biomedical Research on Light and Image

    lead OTHER

Principal Investigators

  • Ingeborg Stalmans, MD · UZ Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Austria
  • Belgium
  • Italy
  • Portugal
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01975714 on ClinicalTrials.gov