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This is a 16 day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketorolac eye drops | Drug | 1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day Placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Post Operative Inflammation | Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = >50 cells) | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Pain | Measured on a scale of 0-4 (0 = none, 4 = intolerable) | Day 1 |
| Mean Pupil Area | Pupil area post-irrigation and aspiration |
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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 |
|---|---|---|---|---|---|---|
| San Diego | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21145532 | Derived | Donnenfeld ED, Nichamin LD, Hardten DR, Raizman MB, Trattler W, Rajpal RK, Alpern LM, Felix C, Bradford RR, Villanueva L, Hollander DA, Schiffman RM. Twice-daily, preservative-free ketorolac 0.45% for treatment of inflammation and pain after cataract surgery. Am J Ophthalmol. 2011 Mar;151(3):420-6.e1. doi: 10.1016/j.ajo.2010.09.003. Epub 2010 Dec 9. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketorolac Solution | |
| FG001 | Vehicle Solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac Solution | |
| BG001 | Vehicle Solution | |
| BG002 | Total |
| 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 | Resolution of Post Operative Inflammation | Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = >50 cells) | Modified Intent-to-Treat Population | Posted | Number | % of participants with a score of 0 | Day 14 |
|
|
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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 | Ketorolac Solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | 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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| Day 0 |
Total of all reporting groups
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Secondary | Ocular Pain | Measured on a scale of 0-4 (0 = none, 4 = intolerable) | Modified Intent-to-Treat Population | Posted | Number | % of participants with a score of 0 | Day 1 |
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| Secondary | Mean Pupil Area | Pupil area post-irrigation and aspiration | Modified Intent-to-Treat Population | Posted | Mean | Standard Deviation | millimeters squared (mm²) | Day 0 |
|
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| Post-Hoc | Visual Acuity | Patients with ≥ 3 line improvement in visual acuity | Modified Intent-to-Treat Population | Posted | Number | Percentage of patients with ≥ 3 lines | Change from baseline at Day 14 |
|
|
|
| 1 |
| 68 |
| EG001 | Vehicle Solution | 0 | 57 |
| Anterior chamber cell | Eye disorders | Systematic Assessment |
|
| Anterior chamber flare | Eye disorders | Systematic Assessment |
|
| Corneal edema | Eye disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Non-systematic Assessment |
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| Iritis | Eye disorders | Systematic Assessment |
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| Photophobia | Eye disorders | Non-systematic Assessment |
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| Intraocular pressure increased | Investigations | Systematic Assessment |
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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.