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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01915940
Other study ID # FSV5-002
Secondary ID
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
Health authority
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

Study Design


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
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