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Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension

NCT01157364 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2020-03-30

Study results available
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Summary

This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.

Conditions

Interventions

DRUG

bimatoprost 20 µg generation 2

Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.

DRUG

bimatoprost 15 µg generation 2

Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

DRUG

bimatoprost 10 µg generation 2

Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

DRUG

bimatoprost 6 µg generation 2

Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

DRUG

bimatoprost 15 µg generation 1

Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.

DRUG

bimatoprost 10 µg generation 1

Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.

DRUG

bimatoprost 0.03%

One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-23
Primary Completion
2016-07-27
Completion
2016-08-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Germany
  • Israel
  • Philippines
  • Singapore
  • Spain

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 NCT01157364 on ClinicalTrials.gov