Clinical trial NCT02358369: Dose-Ranging Study of the Bimatoprost Ocular Insert
Official title: A Phase 2 Prospective, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety and Dose-response of the Bimatoprost Ocular Insert (2.2 mg, 13 mg) With and Without Concomitant Artificial Tears Compared to a Placebo Ocular Insert With and Without Concomitant Timolol (0.5%) Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: ForSight Vision5, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-09
Enrollment: 156
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 Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma or Ocular Hypertension.

This study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).


Eligibility criteria: Key Inclusion Criteria:

* Written informed consent
* At least 18 years of age
* Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension
* Best corrected-distance visual acuity score equivalent to 20/80 or better
* Stable visual field
* Central corneal thickness between 490 - 620 micrometers

Inclusion Criteria at the Randomization Visit:

("T" is defined as time and "hr" is defined as hour\[s\])

* IOP for each eye is ≥ 23 mm Hg at T=0 hr, ≥ 20 mm Hg at T=2 hr and T=8 hr.
* Inter-eye IOP difference of ≤ 5.0 mm Hg at T=0 hr, T=2 hr and T=8 hr.
* IOP for each eye is ≤ 30 mm Hg at T=0 hr, T=2 hr and T=8 hr.

Key Exclusion Criteria:

* Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol
* A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of beta-blocker drops
* Cup-to-disc ratio of 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
* Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date
* Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months
* Past history of any incisional surgery for glaucoma at any time
* Past history of corneal refractive surgery
* Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
* Current participation in an investigational drug or device study or participation in such a study within 30 days of Screening
* Inability to adequately evaluate the retina
* Participants who will require contact lens use during the study period.
* Participants who currently have punctal occlusion
* Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP) at Week 8
timeFrame: Baseline (Day 0) to Week 8
measure: Change From Baseline in IOP at Week 12
timeFrame: Baseline (Day 0) to Week 12
measure: Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8
timeFrame: Baseline (Day 0) to Week 8
measure: Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12
timeFrame: Baseline (Day 0) to Week 12
measure: Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12
timeFrame: Baseline (Day 0) to Week 12
measure: Change From Baseline in Automated Visual Field at Week 12
timeFrame: Baseline (Day 0) to Week 12
measure: Dilated Fundus Exam: Cup-to-Disc-Ratio
timeFrame: Week 12
measure: Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B
timeFrame: Baseline (Day 0) to Week 12
measure: Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C
timeFrame: Week 12 to Week 24
Secondary outcomes:
measure: Change From Baseline in IOP at Week 2
timeFrame: Baseline (Day 0) to Week 2
measure: Change From Baseline in IOP at Week 6
timeFrame: Baseline (Day 0) to Week 6
measure: Change From Baseline in IOP in Period C
timeFrame: Baseline (Day 0) to Weeks 14, 18 and 24
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
city: Artesia
country: United States
facility: Sall Medical Research Center
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Charlotte
country: United States
facility: Mundorf Eye Center
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Health Care
state: North Carolina
city: Madeira
country: United States
facility: Apex Eye
state: Ohio
city: Maryville
country: United States
facility: University of Eye Specialists
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: San Antonio
country: United States
facility: R&R Eye Research, LLC
state: Texas
Study officials:
affiliation: Allergan
name: Michelle Chen, PhD
role: STUDY_DIRECTOR
References: