Dose-Ranging Study of the Bimatoprost Ocular Insert

ForSight Vision5, Inc.156 enrolled

Overview

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%).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

156

Conditions

Primary Open-Angle Glaucoma Ocular Hypertension

Interventions

BimatoprostDRUG

Bimatoprost sustained release Ocular Insert

Timolol 0.5%DRUG

BID drops OU, 0.5% ophthalmic solution

Placebo Ocular InsertDEVICE

Placebo ocular insert OU.

Placebo Eye Drops

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Vold Vision

Fayetteville, Arkansas, United States

Sall Medical Research Center

Artesia, California, United States

Eye Research Foundation

Newport Beach, California, United States

Clayton Eye Center

Outcomes

Primary Outcomes

Change From Baseline in Intraocular Pressure (IOP) at Week 8

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 8. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.

Time frame: Baseline (Day 0) to Week 8

Change From Baseline in 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 an improvement.

Time frame: Baseline (Day 0) to Week 12

Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 8

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

Time frame: Baseline (Day 0) to Week 8

Percentage of Participants by Change From Baseline in Best-corrected Visual Acuity (BCVA) Categories at Week 12

Time frame: Baseline (Day 0) to Week 12

Percentage of Participants With Clinically Significant Change From Baseline in Slit-Lamp Examination Findings at Week 12

The clinician examined and graded the eyelids, conjunctiva, cornea and anterior chamber of the eye with the aid of a slit-lamp, (conjunctival erythema was assessed as part of the examination). Fluorescein dye was instilled into the ocular cul-de-sac to facilitate this examination.

Data from ClinicalTrials.gov

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Placebo eye drops BID OU.

Morrow, Georgia, United States

Mundorf Eye Center

Charlotte, North Carolina, United States

Cornerstone Health Care

High Point, North Carolina, United States

Apex Eye

Madeira, Ohio, United States

University of Eye Specialists

Maryville, Tennessee, United States

Total Eye Care

Memphis, Tennessee, United States

R&R Eye Research, LLC

San Antonio, Texas, United States

Time frame: Baseline (Day 0) to Week 12

Change From Baseline in Automated Visual Field at Week 12

Automated Visual Field was examined used the Humphrey Visual Field Analyzer, a test that measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive change from Baseline indicates improvement.

Time frame: Baseline (Day 0) to Week 12

Dilated Fundus Exam: Cup-to-Disc-Ratio

The cup-to-disk-ratio is an eye test to assess the progression of glaucoma. The diameter of the cup is compared to the diameter of the disk and a ratio is determined. The normal cup-disk ratio is 0.3. An increase in the cup-to-disc-ratio is a possible indication of glaucoma.

Time frame: Week 12

Percentage of Participants by Dilated Fundus Exam Pathology Grade at Week 12

Dilated fundus examination pathology findings were noted, described and graded on a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3). The percentage of participants in each grade is reported.

Time frame: Week 12

Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period A/B

An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. Th investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.

Time frame: Baseline (Day 0) to Week 12

Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity in Period C

An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.

Time frame: Week 12 to Week 24

Secondary Outcomes

Change From Baseline in IOP at Week 2

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 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.

Time frame: Baseline (Day 0) to Week 2

Change From Baseline in 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 an improvement.

Time frame: Baseline (Day 0) to Week 6

Change From Baseline in IOP in Period C

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 Weeks 14, 18 and 24. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement.

Time frame: Baseline (Day 0) to Weeks 14, 18 and 24