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

March 22, 2018 updated by: ForSight Vision5, Inc.

A Phase 2, Multicenter, Randomized, Subject- and Examiner-masked, Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the Bimatoprost Ocular Insert as Compared to Topical Timolol Solution (0.5%) in Patients With Glaucoma or Ocular Hypertension.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Artesia, California, United States, 90701
        • Sall Medical Research Center
      • La Jolla, California, United States, 92037
        • Scripps Clinic Torrey Pines
      • Newport Beach, California, United States, 92663
        • Eye Research Foundation
      • Sacramento, California, United States, 95817
        • UC Davis Dept of Ophthalmology & Vision Science
    • Georgia
      • Atlanta, Georgia, United States, 30076
        • Coastal Research Associates
      • Morrow, Georgia, United States, 30260
        • Clayton Eye Center
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Ophthalmology Consultants
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • UNC Kittner Eye Center
    • Ohio
      • Madeira, Ohio, United States, 45243
        • Apex Eye
    • Texas
      • Fort Worth, Texas, United States, 76102
        • Ophthalmology Associates PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Written informed consent
  • Primary open-angle glaucoma or ocular hypertension in both eyes
  • Best-corrected distance vision of 20/80 or better
  • Stable visual field
  • corneal thickness between 490-620 micrometers

Key Exclusion Criteria:

  • Cup-to-disc ratio greater than 0.8
  • significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than grade 2 based on gonioscopy
  • laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months
  • past history of corneal refractive surgery
  • past history of any incisional surgery for glaucoma at any time
  • corneal abnormalities that would interfere with tonometry readings
  • current participation in an investigational drug or device study or participation in such a study within 30 days of screening
  • Inability to accurately evaluate the retina

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 13 mg Bimatoprost Ocular Insert
Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months.
Drug: Bimatoprost
Bimatoprost ocular insert
Drug: Placebo Eye Drops
Placebo topical eye drops
Device: Placebo Ocular Insert
Ocular insert without any active drug
Other Names:
  • non-medicated (placebo) Ocular Insert
ACTIVE_COMPARATOR: Timolol 0.5% + Placebo Ocular Insert
Washout and placebo ocular insert in each eye for at least 4 weeks, followed by Timolol (timoptic ophthalmic solution 0.5%) twice a day in each eye plus placebo ocular insert for 6 months.
Device: Placebo Ocular Insert
Ocular insert without any active drug
Other Names:
  • non-medicated (placebo) Ocular Insert
Drug: Timolol 0.5%
Timolol 0.5% solution
Other Names:
  • timoptic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
Time Frame: Baseline (Day 0) to Week 2
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Baseline (Day 0) to Week 2
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6
Time Frame: Baseline (Day 0) to Week 6
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Baseline (Day 0) to Week 6
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12
Time Frame: Baseline (Day 0) to Week 12
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Baseline (Day 0) to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in IOP at Month 4
Time Frame: Baseline (Day 1) to Month 4
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 4. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Baseline (Day 1) to Month 4
Change From Baseline in IOP at Month 5
Time Frame: Baseline (Day 0) to Month 5
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 5. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Baseline (Day 0) to Month 5
Change From Baseline in IOP at Month 6
Time Frame: Baseline (Day 0) to Month 6
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.
Baseline (Day 0) to Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ForSight Vision5, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 23, 2013

Primary Completion (ACTUAL)

September 30, 2014

Study Completion (ACTUAL)

November 14, 2014

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (ESTIMATE)

August 5, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2018

Last Update Submitted That Met QC Criteria

March 22, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSV5-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Manuscript
    Information identifier: FSV5-002 Manuscript
    Information comments: peer-reviewed publication of primary results from FSV5-002 study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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