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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004587-29 | EudraCT Number |
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The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypertension.
This study consisted of six visits conducted during two sequential phases. The Screening/Eligibility phase included one screening visit and two eligibility visits. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1) at the second eligibility visit. The Treatment phase consisted of three on-therapy visits (Week 2, Week 6, and Month 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Travoprost 0.003% | Experimental | Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months |
|
| TRAVATAN | Active Comparator | Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travoprost ophthalmic solution, 0.003% | Drug |
| ||
| Travoprost ophthalmic solution, 0.004% |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). | Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theresa A Landry, PhD | Alcon Research | Study Director |
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Of the 1099 enrolled, 235 did not meet inclusion/exclusion criteria and were exited from the study prior to randomization. This reporting group includes all randomized subjects (864).
Subjects were recruited from 60 investigational centers, including 52 in the US, 2 each in Sweden, Germany, and Austria, and 1 each in Spain and Finland.
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| ID | Title | Description |
|---|---|---|
| FG000 | Travoprost 0.003% | Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months |
| FG001 | TRAVATAN | Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This reporting group includes subjects exposed to the study medication. Note: One subject in the TRAVATAN arm was randomized but discontinued prior to exposure to study medication and is not included in this reporting group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Travoprost 0.003% | Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months |
| BG001 | TRAVATAN | Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM) | As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). | The intent-to-treat (ITT) analysis set included all patients who received study drug and completed at least 1 scheduled on-therapy study visit. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. | Posted | Least Squares Mean | Standard Error | millimeters mercury (mmHg) | Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM) |
|
Adverse events were collected from time of enrollment to study completion. An adverse event was considered to be any untoward medical occurrence in a patient exposed to the study medication.
This reporting group includes subjects exposed to the study medication.
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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 | Travoprost 0.003% | Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular hyperaemia | Eye disorders | MedDRA 14.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theresa A Landry, PhD | 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 |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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| Drug |
|
|
| Patient Decision Unrel to Adverse Event |
|
| Noncompliance |
|
| Inadequate Control of IOP |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | TRAVATAN | Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months |
|
|
| 5 |
| 442 |
| 56 |
| 442 |
| EG001 | TRAVATAN | Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months | 7 | 421 | 64 | 421 |
| Chest Pain | General disorders | MedDRA 14.0 |
|
| Collapse of lung | Injury, poisoning and procedural complications | MedDRA 14.0 |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.0 |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 14.0 |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 |
|
| Cellulitis | Infections and infestations | MedDRA 14.0 |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.0 |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 14.0 |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 14.0 |
|
| Erysipelas | Infections and infestations | MedDRA 14.0 |
|
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 14.0 |
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| Conjunctival hyperaemia | Eye disorders | MedDRA 14.0 |
|
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 |