Clinical trial NCT01915940: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open-Angle Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Primary Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: ForSight Vision5, Inc.
Sponsor class: INDUSTRY
First posted: 2013-08-05
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2
timeFrame: Baseline (Day 0) to Week 2
measure: Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6
timeFrame: Baseline (Day 0) to Week 6
measure: Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12
timeFrame: Baseline (Day 0) to Week 12
Secondary outcomes:
measure: Change From Baseline in IOP at Month 4
timeFrame: Baseline (Day 1) to Month 4
measure: Change From Baseline in IOP at Month 5
timeFrame: Baseline (Day 0) to Month 5
measure: Change From Baseline in IOP at Month 6
timeFrame: Baseline (Day 0) to Month 6
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Medical Research Center
state: California
city: La Jolla
country: United States
facility: Scripps Clinic Torrey Pines
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Sacramento
country: United States
facility: UC Davis Dept of Ophthalmology & Vision Science
state: California
city: Atlanta
country: United States
facility: Coastal Research Associates
state: Georgia
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Saint Louis
country: United States
facility: Ophthalmology Consultants
state: Missouri
city: Chapel Hill
country: United States
facility: UNC Kittner Eye Center
state: North Carolina
city: Madeira
country: United States
facility: Apex Eye
state: Ohio
city: Fort Worth
country: United States
facility: Ophthalmology Associates PC
state: Texas
Study officials:
affiliation: Allergan
name: Michelle Chen, PhD
role: STUDY_DIRECTOR
References:
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.