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The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with travoprost 0.004% / timolol 0.5% compared to beta-blocker monotherapy in participants with open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DuoTrav | Experimental | Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 8 weeks. |
|
| Beta-blocker | Active Comparator | Participant's current beta-blocker monotherapy, 1 drop instilled in the study eye twice daily (morning and evening) for 4 weeks, followed by travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution, 1 drop instilled in the study eye once daily (evening) for 4 additional weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta-blocker monotherapy | Drug | Per participant's current prescribed therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis. | Baseline (Day 0), Week 4 |
| Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Project Lead GCRA, Pharma | Alcon Research | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28239491 | Derived | Lerner SF, Park KH, Hubatsch DA, Erichev V, Paczka JA, Roberts TV. Efficacy and Tolerability of Travoprost 0.004%/Timolol 0.5% Fixed-Dose Combination for the Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Inadequately Controlled with Beta-Blocker Monotherapy. J Ophthalmol. 2017;2017:1917570. doi: 10.1155/2017/1917570. Epub 2017 Jan 23. |
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Of the 157 participants enrolled, 1 participant was exited as a screen failure. This reporting group includes all randomized participants (156).
Participants were recruited from 14 investigational centers located in Latin America, Australia, Russia, and Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | DuoTrav | Travoprost/timolol for 8 weeks |
| FG001 | Beta-blocker | 4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Intent to treat population included participants who received study medication and had at least one on-therapy study visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | DuoTrav | Travoprost/timolol for 8 weeks |
| BG001 | Beta-blocker | 4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. | Intent to treat with a measurement in the study eye at Week 4 | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Week 4 |
|
Reporting of adverse events (AEs) began once informed consent was obtained from the participant and continued through study exit at week 8. Ocular AEs are presented for both study eye and non-study eye combined.
An AE was defined as any untoward medical occurrence in a participant who was administered study treatment regardless of whether or not the event had a causal relationship to study treatment. AEs were reported as pre-treatment and treatment-emergent. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DuoTrav | Travoprost/timolol for 8 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharal pigmentation | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Brand Leader, Medical Affairs, Glaucoma | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| D013999 | Timolol |
| C571754 | Duotrav |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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| Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution |
| Drug |
|
|
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. |
| Baseline (Day 0), Week 4 |
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis. | Intent to treat with a measurement in the study eye at Week 4 | Posted | Mean | Standard Deviation | mmHg | Baseline (Day 0), Week 4 |
|
|
|
| Secondary | Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis. | Intent to treat with a measurement in the study eye at Week 4 | Posted | Mean | Standard Deviation | Percent Change | Baseline (Day 0), Week 4 |
|
|
|
| 0 |
| 81 |
| 18 |
| 81 |
| EG001 | Beta-blocker | 4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol | 0 | 75 | 9 | 75 |
| Cataract | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Eyelids pruritus | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Ocular surface disease | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
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| Acute tonsillitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |