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Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost 0.03% eye drops | Drug | bimatoprost 0.03% 1 drop nightly for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | Intraocular Pressure | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability - Conjunctival Hyperemia | Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe) | Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Affairs | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19726422 | Background | Kammer JA, Katzman B, Ackerman SL, Hollander DA. Efficacy and tolerability of bimatoprost versus travoprost in patients previously on latanoprost: a 3-month, randomised, masked-evaluator, multicentre study. Br J Ophthalmol. 2010 Jan;94(1):74-9. doi: 10.1136/bjo.2009.158071. Epub 2009 Sep 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost | bimatoprost 0.03% 1 drop nightly for 3 months |
| FG001 | Travoprost | travoprost 0.004% 1 drop nightly for 3 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost | bimatoprost 0.03% 1 drop nightly for 3 months |
| BG001 | Travoprost | travoprost 0.004% 1 drop nightly for 3 months |
| 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 | Intraocular Pressure (IOP) | Intraocular Pressure | Posted | Mean | Standard Deviation | mm Hg | Month 3 |
|
|
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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 | Bimatoprost | bimatoprost 0.03% 1 drop nightly for 3 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular Hyperaemia | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs | Allergan, Inc. | (714)246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| D009883 | Ophthalmic Solutions |
| D000069557 | Travoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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| travoprost 0.004% eye drops | Drug | travoprost 0.004% 1 drop nightly for 3 months |
|
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Tolerability - Conjunctival Hyperemia | Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe) | Posted | Number | participants | Month 3 |
|
|
|
| 1 |
| 131 |
| 21 |
| 131 |
| EG001 | Travoprost | travoprost 0.004% 1 drop nightly for 3 months | 0 | 133 | 22 | 133 |
| Eye Pruritus | Eye disorders | Non-systematic Assessment |
|
| Conjunctival Hyperaemia | Eye disorders | Non-systematic Assessment |
|
| Punctate keratitis | Eye disorders | Non-systematic Assessment |
|
| Eye Irritation | Eye disorders | Non-systematic Assessment |
|
| Growth of Eyelashes | Eye disorders | Non-systematic Assessment |
|
| Visual Acuity Reduced | Eye disorders | Non-systematic Assessment |
|
| Abnormal Sensation in Eye | Eye disorders | Non-systematic Assessment |
|
| Eye Discharge | Eye disorders | Non-systematic Assessment |
|
| Eyelid Margin Crusting | Eye disorders | Non-systematic Assessment |
|
| Lenticular Opacities | Eye disorders | Non-systematic Assessment |
|
| Instillation Site Pruritus | General disorders | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Sensation of Foreign Body | General disorders | Non-systematic Assessment |
|
| Conjunctivitis Viral | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pigmentation Disorder | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomach Discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Foreign Body in Eye | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Hyperaemia | Vascular disorders | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | Non-systematic Assessment |
|
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| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |