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.