Dose-Ranging Study of the Bimatoprost Ocular Insert

Condition(s) targeted: Primary Open-Angle Glaucoma; Ocular Hypertension

Intervention: Bimatoprost (Drug); Timolol (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: ForSight Vision5, Inc.

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 will evaluate 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%).

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 (2.2mg, 13mg) 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change in IOP from baseline

Safety assessed by ophthalmic examination including best-corrected visual acuity, slit lamp exam, automated visual field, and dilated fundus exam.

Secondary outcome: Change in IOP from baseline

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

- IOP for each eye is ≥ 23 mmHg at T=0hr, ≥ 20 mmHg at T=2hr and T=8hr.

- Inter-eye IOP difference of ≤ 5. 0 mmHg at T=0hr, T=2hr and T=8hr.

- IOP for each eye is ≤ 30 mmHg at T=0hr, T=2hr and T=8hr.

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

- Subjects who will require contact lens use during the study period.

- Subjects who currently have punctal occlusion

- Pregnant, lactating or of child-bearing potential and not using a medically

acceptable form of birth control

Sall Medical Research Center, Artesia, California 90701, United States

Starting date: January 2015
Last updated: June 9, 2015