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A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension

NCT02742649 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2019-02-25

Study results available
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Summary

The purpose of this study is to determine if a combination of two drugs (bimatoprost and timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular pressure (IOP) than either of the drugs delivered alone.

Conditions

Interventions

DRUG

Fixed Combination

Continuous elution from the ocular insert.

DRUG

Bimatoprost

Continuous elution from the ocular insert. This is an active control arm.

DRUG

Timolol

Continuous elution from the ocular insert. This is an active control arm.

DEVICE

Placebo Segment

One segment of placebo (no drug product)

DRUG

Timolol 0.5%

0.5% timolol drops twice daily.

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
2016-04-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Panama

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 NCT02742649 on ClinicalTrials.gov