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

Status:	Completed
Conditions:	High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:	Cardiology / Vascular Diseases, Ophthalmology
Healthy:	No
Age Range:	18 - Any
Updated:	4/22/2018
Start Date:	October 23, 2013
End Date:	November 14, 2014

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

We found this trial at

sites

Apex Eye

Madeira, Ohio 45243

from

Madeira, OH