Efficacy of Changing to DUOTRAV® From Prior Therapy

Study Overview
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Brief Summary
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The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).

Official Title
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Assessing the Efficacy and Tolerability of Changing to DUOTRAV® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination), as Replacement Therapy in Patients Previously on Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)

Conditions
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Open-Angle Glaucoma, Ocular Hypertension, Pigment Dispersion Glaucoma

Intervention / Treatment
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* Drug: Travoprost 0.004%+Timolol 0.5% ophthalmic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of ocular hypertension, open-angle or pigment dispersion glaucoma in at least one eye. Stable IOP-lowering regimen of bimatoprost 0.03%/timolol 0.5% therapy (either administered concomitantly or in a fixed combination) within 4 weeks prior to the screening visit. IOP considered to be safe (in the opinion of the investigator), in both eyes, to assure clinical stability of vision and the optic nerve throughout the study period. IOP between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye). Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study. Able to follow instructions and willing and able to attend all study visits. Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye. Sign informed consent. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator. Corneal dystrophies in either eye. Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment. Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. History of severe allergic rhinitis. A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject. Participation in any other investigational study within 30 days prior to the Screening Visit. 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DUOTRAV®<br>Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks | Drug: Travoprost 0.004%+Timolol 0.5% ophthalmic solution<br>* Fixed dose combination topical ocular agent preserved with polyquaternium-1 (POLYQUAD)<br>* Other names: DUOTRAV®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline | IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline | The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative number change from baseline represents a perceived improvement in ocular health. | Week 12 | 
| Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline | Ocular hyperemia (visible eye redness) was assessed during slit lamp examination and graded on a 5-point scale (0=none, 4=severe). A positive number change from baseline indicates an increase in ocular redness. One eye was chosen as the study eye, and only the study eye was used for analysis. | Week 12 | 
| Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline | IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. An increase in intraocular pressure may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis. | Week 4, Week 12 | 
| Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline | IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis. | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open-angle glaucoma, Ocular hypertension, Pigment dispersion glaucoma, Intraocular pressure