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®)

Phase 4

Completed

• Conditions: Glaucoma; Ocular Hypertension; Open-Angle Glaucoma
• Interventions: Drug: Travoprost 0.004% ophthalmic solution; Drug: Bimatoprost 0.01% ophthalmic solution

• Registration Number: NCT01464424
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-03
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2013-06-26
• Results First Submitted QC: 2013-06-26
• Status Verified: 2013-09
• Results First Posted: 2013-09-04
• Last Update Submitted: 2013-09-05
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TRAVATAN, then LUMIGAN	Travoprost 0.004% ophthalmic solution	Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks
TRAVATAN, then LUMIGAN	Bimatoprost 0.01% ophthalmic solution	Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks
LUMIGAN, then TRAVATAN	Travoprost 0.004% ophthalmic solution	Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks
LUMIGAN, then TRAVATAN	Bimatoprost 0.01% ophthalmic solution	Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks

Primary Outcome Measures

Name	Time	Method
Overall Mean Intraocular Pressure (IOP)	Week 6	IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis.

Secondary Outcome Measures

Name	Time	Method
Mean IOP at Each After Office Hour Evaluation Timepoint	Week 6: 4 pm, 6 pm, 8 pm	IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye.