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

Primary Purpose

Primary Open-Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost
Timolol 0.5%
Placebo Eye Drops
Placebo Ocular Insert
Sponsored by
ForSight Vision5, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-Angle Glaucoma focused on measuring Glaucoma, Primary Open-Angle Glaucoma, Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sall Medical Research Center
  • Scripps Clinic Torrey Pines
  • Eye Research Foundation
  • UC Davis Dept of Ophthalmology & Vision Science
  • Coastal Research Associates
  • Clayton Eye Center
  • Ophthalmology Consultants
  • UNC Kittner Eye Center
  • Apex Eye
  • Ophthalmology Associates PC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

13 mg Bimatoprost Ocular Insert

Timolol 0.5% + Placebo Ocular Insert

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Intra-Ocular Pressure (IOP) at 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.
Change From Baseline in Intra-Ocular Pressure (IOP) at 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.
Change From Baseline in Intra-Ocular Pressure (IOP) at 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.

Secondary Outcome Measures

Change From Baseline in IOP at 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.
Change From Baseline in IOP at 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.
Change From Baseline in IOP at 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.

Full Information

First Posted
July 31, 2013
Last Updated
March 22, 2018
Sponsor
ForSight Vision5, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01915940
Brief Title
Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 23, 2013 (Actual)
Primary Completion Date
September 30, 2014 (Actual)
Study Completion Date
November 14, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ForSight Vision5, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-Angle Glaucoma, Ocular Hypertension
Keywords
Glaucoma, Primary Open-Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
13 mg Bimatoprost Ocular Insert
Arm Type
Experimental
Arm Description
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.
Arm Title
Timolol 0.5% + Placebo Ocular Insert
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost
Intervention Description
Bimatoprost ocular insert
Intervention Type
Drug
Intervention Name(s)
Timolol 0.5%
Other Intervention Name(s)
timoptic
Intervention Description
Timolol 0.5% solution
Intervention Type
Drug
Intervention Name(s)
Placebo Eye Drops
Intervention Description
Placebo topical eye drops
Intervention Type
Device
Intervention Name(s)
Placebo Ocular Insert
Other Intervention Name(s)
non-medicated (placebo) Ocular Insert
Intervention Description
Ocular insert without any active drug
Primary Outcome Measure Information:
Title
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
Description
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.
Time Frame
Baseline (Day 0) to Week 2
Title
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6
Description
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.
Time Frame
Baseline (Day 0) to Week 6
Title
Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12
Description
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.
Time Frame
Baseline (Day 0) to Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in IOP at Month 4
Description
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.
Time Frame
Baseline (Day 1) to Month 4
Title
Change From Baseline in IOP at Month 5
Description
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.
Time Frame
Baseline (Day 0) to Month 5
Title
Change From Baseline in IOP at Month 6
Description
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.
Time Frame
Baseline (Day 0) to Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Chen, PhD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Sall Medical Research Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Scripps Clinic Torrey Pines
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
UC Davis Dept of Ophthalmology & Vision Science
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Coastal Research Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Clayton Eye Center
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Ophthalmology Consultants
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
UNC Kittner Eye Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Apex Eye
City
Madeira
State/Province
Ohio
ZIP/Postal Code
45243
Country
United States
Facility Name
Ophthalmology Associates PC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35076329
Citation
Belamkar A, Harris A, Zukerman R, Siesky B, Oddone F, Verticchio Vercellin A, Ciulla TA. Sustained release glaucoma therapies: Novel modalities for overcoming key treatment barriers associated with topical medications. Ann Med. 2022 Dec;54(1):343-358. doi: 10.1080/07853890.2021.1955146.
Results Reference
derived

Learn more about this trial

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

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