Dose-Ranging Study of the Bimatoprost Ocular Insert

ForSight Vision5

Status and phase: Completed; Phase 2

Conditions: Primary Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Bimatoprost; Drug: Placebo Eye Drops; Device: Placebo Ocular Insert; Drug: Timolol 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02358369

FSV5-004

Details and patient eligibility

About

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%).

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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156 participants in 3 patient groups

13 mg Bimatoprost Ocular Insert

Experimental group

Description:

Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye (OU) for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops to each eye twice a day (BID) for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.

Treatment:

Drug: Bimatoprost

Drug: Placebo Eye Drops

Device: Placebo Ocular Insert

2.2 mg Bimatoprost Ocular Insert

Experimental group

Description:

Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 2.2 mg Bimatoprost Ocular Insert in each eye for 12 weeks. Note: participants also self-administered placebo ophthalmic eye drops in each eye twice a day for the first 6 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.

Treatment:

Drug: Bimatoprost

Drug: Placebo Eye Drops

Device: Placebo Ocular Insert

Timolol 0.5%

Active Comparator group

Description:

Washout + Placebo Ocular Insert in each eye for 4 to 6 weeks, followed by 0.5% timolol ophthalmic solution in each eye for 6 weeks. Note: participants simultaneously wore placebo ocular inserts for 12 weeks. After 12 weeks, 13 mg Bimatoprost Ocular Insert in each eye for an additional 12 weeks.

Treatment:

Drug: Bimatoprost

Device: Placebo Ocular Insert

Drug: Timolol 0.5%