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®)

Study Overview
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Brief Summary
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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.

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

Conditions
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Glaucoma, Ocular Hypertension, Open-Angle Glaucoma

Intervention / Treatment
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* Drug: Travoprost 0.004% ophthalmic solution
* Drug: Bimatoprost 0.01% ophthalmic solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TRAVATAN, then LUMIGAN<br>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 | Drug: Travoprost 0.004% ophthalmic solution<br> <br> * Other names: TRAVATAN® Z;Drug: Bimatoprost 0.01% ophthalmic solution<br> <br> * Other names: LUMIGAN®;|
| Other: LUMIGAN, then TRAVATAN<br>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 | Drug: Travoprost 0.004% ophthalmic solution<br> <br> * Other names: TRAVATAN® Z;Drug: Bimatoprost 0.01% ophthalmic solution<br> <br> * Other names: LUMIGAN®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Mean Intraocular Pressure (IOP) | 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. | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP at Each After Office Hour Evaluation Timepoint | 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. | Week 6: 4 pm, 6 pm, 8 pm | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Ocular Hypertension, Open-Angle Glaucoma, Intraocular Pressure