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Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension

NCT01915940 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2018-04-20

Study results available
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Summary

The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.

Conditions

Interventions

DRUG

Bimatoprost

Bimatoprost ocular insert

DRUG

Timolol 0.5%

Timolol 0.5% solution

DRUG

Placebo Eye Drops

Placebo topical eye drops

DEVICE

Placebo Ocular Insert

Ocular insert without any active drug

Sponsors & Collaborators

  • ForSight Vision5, Inc.

    lead INDUSTRY

Principal Investigators

  • Michelle Chen, PhD · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-23
Primary Completion
2014-09-30
Completion
2014-11-14

Countries

  • United States

Study Locations

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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 NCT01915940 on ClinicalTrials.gov