Overview

Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension

Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
Treatments:
Brimonidine Tartrate
Brinzolamide
Maleic acid
Timolol
Criteria
Inclusion Criteria:

- Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.

- Willing and able to attend all study-related visits and be housed overnight at
clinical site for the study assessments.

- Must sign an Informed Consent form.

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Women of childbearing potential if pregnant, breastfeeding, or not using adequate
birth control.

- Severe central visual field loss in either eye.

- Chronic, recurrent or severe inflammatory eye disease.

- Ocular trauma or ocular surgery within the past 6 months.

- Ocular infection or ocular inflammation within the past 3 months.

- Clinically significant or progressive retinal disease.

- Other ocular pathology, including severe dry eye, that may in the opinion of the
investigator preclude the administration of study medication.

- Any other conditions including severe illness which would make the patient, in the
opinion of the Investigator, unsuitable for the study.

- Any medical condition that would preclude the safe administration of a topical
beta-blocker.

- Cannot safely discontinue all glucocorticoids administered by any route.

- Other protocol-specified exclusion criteria may apply.