Overview

Divided Dose of TRAVATAN®

Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the incremental dosing of travoprost ophthalmic solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
Treatments:
Ophthalmic Solutions
Pharmaceutical Solutions
Travoprost
Criteria
Inclusion Criteria:

- Patients with open-angle glaucoma or ocular hypertension who meet the following IOP
criteria:

1. Mean IOP ≥ 24 mmHg in at least 1 eye, with the same eye qualifying at 8 AM at
both Day 0 and Day 1;

2. Mean IOP ≤ 36 mmHg in both eyes at all time points on Day 0 and Day 1.

- Must sign an informed consent form.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Females of childbearing potential who are pregnant, test positive on urine pregnancy
test at the Screening Visit, intend to become pregnant during the study period, are
breast-feeding, or are not using highly effective birth control measures.

- Current or history of ocular inflammation or infection in either eye within the past 3
months.

- Corneal thickness greater than 620 µm as determined by pachymetry in either eye.

- Severe visual field loss.

- Cup to disc ratio greater than 0.8 in either eye.

- Intraocular surgery within the past 6 months in either eye.

- Other protocol-defined exclusion criteria may apply.