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

A Phase 2, Multicenter, Randomized, Subject- and Examiner-masked, Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the Bimatoprost Ocular Insert as Compared to Topical Timolol Solution (0.5%) in Patients With Glaucoma or Ocular Hypertension.

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.

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