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

Ocular Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915940
• Other study ID #: FSV5-002
• Status: Completed
• Phase: Phase 2
• First received: July 31, 2013
• Last updated: March 22, 2018
• Start date: October 23, 2013
• Est. completion date: November 14, 2014

Study information

• Verified date: March 2018
• Source: ForSight Vision5, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: November 14, 2014
• Est. primary completion date: September 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open-Angle Glaucoma

Intervention

Drug:
• Bimatoprost
Bimatoprost ocular insert
• Timolol 0.5%
Timolol 0.5% solution
• Placebo Eye Drops
Placebo topical eye drops

Device:
• Placebo Ocular Insert
Ocular insert without any active drug

Locations

Country	Name	City	State
United States	Sall Medical Research Center	Artesia	California
United States	Coastal Research Associates	Atlanta	Georgia
United States	UNC Kittner Eye Center	Chapel Hill	North Carolina
United States	Ophthalmology Associates PC	Fort Worth	Texas
United States	Scripps Clinic Torrey Pines	La Jolla	California
United States	Apex Eye	Madeira	Ohio
United States	Clayton Eye Center	Morrow	Georgia
United States	Eye Research Foundation	Newport Beach	California
United States	UC Davis Dept of Ophthalmology & Vision Science	Sacramento	California
United States	Ophthalmology Consultants	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
ForSight Vision5, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Day 0) to Week 2
Primary	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.	Baseline (Day 0) to Week 6
Primary	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.	Baseline (Day 0) to Week 12
Secondary	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.	Baseline (Day 1) to Month 4
Secondary	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.	Baseline (Day 0) to Month 5
Secondary	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.	Baseline (Day 0) to Month 6