Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.

Official Title
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Comparison of Safety and IOP-Lowering Efficacy of Three Alternative Travoprost Formulations to Vehicle and TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
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Ocular Hypertension, Open-angle Glaucoma

Intervention / Treatment
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* Drug: Travoprost ophthalmic solution (new formulation)
* Drug: Travoprost ophthalmic solution, 0.004%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Satisfy all informed consent requirements; Diagnosed with open-angle glaucoma or ocular hypertension; Able to discontinue use of all IOP-lowering medications for a minimum of 5 to 28 days prior to the Eligibility 1 Visit; IOP measurements in at least 1 eye as specified in protocol; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Females of childbearing potential if pregnant, breastfeeding, or not using highly effective birth control measures; Any form of glaucoma other than open-angle glaucoma; Severe central visual field loss in either eye; Chronic, recurrent or severe inflammatory eye disease; Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment, in the opinion of the Investigator; Best-corrected visual acuity (BCVA) worse than 0.60 logarithm of the miniminum angle of resolution (logMAR); Intraocular surgery within the past 6 months; Ocular laser surgery within the past 3 months; Any abnormality preventing reliable applanation tonometry; Severe illness or any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study; Other protocol-specified 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost new formulation<br>Travoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks | Drug: Travoprost ophthalmic solution (new formulation)<br> <br> |
| Active Comparator: TRAVATAN<br>Travoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks | Drug: Travoprost ophthalmic solution, 0.004%<br> <br> * Other names: TRAVATAN Z®;|
| Placebo Comparator: Vehicle<br>Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks | Drug: Vehicle<br>* Inactive ingredients used as a placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in intraocular pressure (IOP) | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. | Baseline, Up to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean intraocular pressure | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). | Baseline, Up to Week 4 | 
| Mean percent change from baseline in IOP | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change indicates a greater amount of improvement. | Baseline, Up to Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IOP, Open-angle glaucoma, Ocular Hypertension