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Study terminated due to corporate decision.
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The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bimatoprost ophthalmic solution formulation A and vehicle | Experimental | 1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks. |
|
| timolol ophthalmic solution | Active Comparator | 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost ophthalmic solution formulation A | Drug | 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure. | Baseline, Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisville | Kentucky | United States | ||||
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The study was discontinued prematurely after enrollment of 6 patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost Ophthalmic Solution Formulation A and Vehicle | 1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| timolol ophthalmic solution | Drug | 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks. |
|
| bimatoprost vehicle | Drug | 1 drop of bimatoprost vehicle in the affected eye(s) in the morning for 6 weeks, followed by 1 drop of bimatoprost vehicle in the affected eye(s) in the evening for 6 weeks. |
|
| Amiens |
| France |
| Milan | Italy |
| Parma | Italy |
| City of Taguig | Philippines |
| Makati | Philippines |
| Seoul | South Korea |
| Taipei | Taiwan |
| London | United Kingdom |
| FG001 | Timolol Ophthalmic Solution | 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost Ophthalmic Solution Formulation A and Vehicle | 1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks. |
| BG001 | Timolol Ophthalmic Solution | 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Change From Baseline in Intraocular Pressure (IOP) in the Study Eye | IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure. | Due to early termination of the study, no statistical analysis was performed and no data summaries were generated. From a target of 120 patients, only 6 patients (3 in each group) were enrolled. | Posted | Baseline, Week 6 |
|
|
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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 Ophthalmic Solution Formulation A and Vehicle | 1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks. | 0 | 3 | 3 | 3 | ||
| EG001 | Timolol Ophthalmic Solution | 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks. | 0 | 3 | 1 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelash Hyperpigmentation | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Growth of Eyelashes | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Intraocular Pressure Increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
| |
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Eyelid Oedema | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
| |
| Blepharal Pigmentation | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| Male |
|