Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension

ForSight Vision5

Status and phase: Completed; Phase 2

Conditions: Primary Open-Angle Glaucoma; Ocular Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01915940

FSV5-002

Details and patient eligibility

About

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.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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169 participants in 2 patient groups

13 mg Bimatoprost Ocular Insert

Experimental group

Description:

Washout and placebo ocular insert in each eye for at least 4 weeks, followed by 13 mg Bimatoprost Ocular Insert in each eye and placebo eye drops twice a day in each eye for 6 months.

Treatment:

Drug: Bimatoprost

Drug: Placebo Eye Drops

Device: Placebo Ocular Insert

Timolol 0.5% + Placebo Ocular Insert

Active Comparator group

Description:

Washout and placebo ocular insert in each eye for at least 4 weeks, followed by Timolol (timoptic ophthalmic solution 0.5%) twice a day in each eye plus placebo ocular insert for 6 months.

Treatment:

Drug: Timolol 0.5%

Device: Placebo Ocular Insert