A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.

Conditions
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Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
* Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older. Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes. Best corrected visual acuity of 20/200 Snellen or better in each eye. Intraocular pressure within protocol-specified range. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any abnormality preventing reliable applanation tonometry in the study eye(s). Any eye conditions or procedures as specified in protocol. Progressive retinal or optic nerve disease from any cause. Use of contact lenses in the study eye(s). 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost<br>Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned. | Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)<br>* Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost.<br>* Other names: TRAVATAN Z®;|
| Active Comparator: Latanoprost<br>Latanoprost assigned to one eye, with travoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned. | Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)<br>* Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.<br>* Other names: XALATAN®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort Immediately After Dosing | Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable. | 5 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comfort