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Dose-Ranging Study of the Bimatoprost Ocular Insert

NCT02358369 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2020-06-04

Study results available
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Summary

The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma or Ocular Hypertension.

This study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).

Conditions

Interventions

DRUG

Bimatoprost

Bimatoprost sustained release Ocular Insert

DRUG

Timolol 0.5%

BID drops OU, 0.5% ophthalmic solution

DEVICE

Placebo Ocular Insert

Placebo ocular insert OU.

DRUG

Placebo Eye Drops

Placebo eye drops BID OU.

Sponsors & Collaborators

  • ForSight Vision5, Inc.

    lead INDUSTRY

Principal Investigators

  • Michelle Chen, PhD · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-19
Primary Completion
2015-08-31
Completion
2015-10-07

Countries

  • United States

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 NCT02358369 on ClinicalTrials.gov