Overview

Assessment of Intraocular Pressure (IOP) Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®)

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs. bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with open-angle glaucoma or ocular hypertension after 6 weeks of treatment.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
Treatments:
Bimatoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Travoprost
Criteria
Inclusion Criteria:

- Clinical diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in at
least one eye.

- Non-study eye: Intraocular pressure (IOP) able to be controlled with no pharmacologic
therapy or on the study medicine alone.

- Willing to discontinue the use of all other ocular hypotensive medications prior to
receiving study medication and for the entire course of the study.

- Able to follow instructions, self instill study article, and attend all study visits.

- Best-corrected Snellen visual acuity of 20/200 or better in each eye.

- Sign Ethics Committee reviewed and approved informed consent form.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Known medical history of allergy, hypersensitivity or poor tolerance to any component
of the preparations used in this study.

- Any abnormality preventing applanation tonometry in either eye.

- Dry eye previously or currently being treated with punctal plugs, punctal cautery,
Restasis®, or topical ocular corticosteroids.

- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either
eye.

- Intraocular conventional or laser surgery >3 months prior to consent.

- Risk of visual field or visual acuity worsening as a consequence of participation in
the study, in the investigator's best judgment.

- Progressive retinal or optic nerve disease from any cause.

- Use of any systemic medications known to affect IOP which have not been on a stable
course for at least 7 days prior to Screening or an anticipated change in dosage
during the course of the study.

- Any clinically significant, serious, or severe medical condition.

- Women of childbearing potential who are pregnant, lactating, or not using reliable
means of birth control.

- Participation in any other study within 30 days prior to Screening.

- Use of any systemic (oral), injectable or topical steroids.

- Other protocol-defined exclusion criteria may apply.