Completed

A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Bimatoprost 0.01%

+ Bimatoprost 0.03%

Drug
Who is being recruted

Eye Diseases

+ Glaucoma

+ Ocular Hypertension

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2013
See protocol details

Summary

Principal SponsorAllergan
Last updated: May 6, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2013

Actual date on which the first participant was enrolled.

This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).

NCT01830140
Principal SponsorAllergan
Last updated: May 6, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

466 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesGlaucomaOcular Hypertension

Criteria

1 inclusion criteria required to participate
Diagnosis of glaucoma or ocular hypertension
2 exclusion criteria prevent from participating
Active ocular disease other than glaucoma or ocular hypertension
Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.

Group II

Active Comparator
Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Artesia, United StatesOpen in Google Maps

El Paso, United States
Completed2 Study Centers