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Study terminated due to corporate decision.
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This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior segment inflammation and pain following cataract extraction with lens implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone Drug Delivery System | Experimental | Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. |
|
| Placebo Drug Delivery System | Placebo Comparator | Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Drug Delivery System | Drug | Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Clearance of Anterior Chamber Inflammation | The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst). | Up to Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Levels of Dexamethasone | Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood. | Day 2, Day 7, Day 14 |
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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 |
|---|---|---|---|---|---|---|
| Newport Beach | California | United States |
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This study was terminated due to corporate decision and enrollment was not completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone Drug Delivery System | Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. |
| FG001 | Placebo Drug Delivery System | Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone Drug Delivery System | Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. |
| BG001 | Placebo Drug Delivery System |
| 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 | Number of Patients With Clearance of Anterior Chamber Inflammation | The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst). | Safety: all patients who received study treatment at randomization/surgery (day 1) | Posted | Number | Patients | Up to Day 71 |
|
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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 | Dexamethasone Drug Delivery System | Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Oedema | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior Chamber Cell | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Placebo Drug Delivery System | Drug | Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. |
|
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Plasma Levels of Dexamethasone | Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood. | Pharmacokinetic: all patients who received dexamethasone and consented to pharmacokinetic analysis. | Posted | Mean | Standard Deviation | Nanograms/Milliliter (ng/mL) | Day 2, Day 7, Day 14 |
|
|
|
| 2 |
| 6 |
| 6 |
| 6 |
| EG001 | Placebo Drug Delivery System | Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1. | 0 | 2 | 2 | 2 |
| Retinal Tear | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Anterior Chamber Flare | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Corneal Oedema | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Conjunctival Oedema | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Corneal Deposits | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
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| Intraocular Pressure Increased | Investigations | MedDRA version 16.0 | Systematic Assessment |
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| Iris Adhesions | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
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| Punctate Keratitis | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
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| Conjunctival Hyperaemia | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Visual Acuity Reduced | Eye disorders | MedDRA version 16.0 | Non-systematic Assessment |
|
| Eye Pain | Eye disorders | MedDRA version 16.0 | Non-systematic Assessment |
|
| Eye Pruritus | Eye disorders | MedDRA version 16.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Photophobia | Eye disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Facial Pain | General disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Conjunctival Haemorrhage | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Foreign Body Sensation in Eyes | Eye disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Glare | Eye disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Halo Vision | Eye disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Retinal Degeneration | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
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| Retinal Tear | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Vitreous Detachment | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Eyelid Oedema | Eye disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Lacrimation Increased | Eye disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Photopsia | Eye disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Posterior Capsule Opacification | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
|
| Vitreous Floaters | Eye disorders | MedDRA version 16.0 | 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 | Measurements |
|---|---|
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