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

• Status: Completed
• Trial end date: 2014-11-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ForSight Vision5, Inc.
• Treatments: Bimatoprost; Ophthalmic Solutions; Pharmaceutical Solutions; Timolol

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