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Study of T-PRED(TM) compared to Pred Forte(R)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-Pred | Active Comparator | Tobramycin prednisolone acetate combination |
|
| Pred Forte | Active Comparator | Prednisolone acetate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-PRED | Drug | T-PRED sterile ophthalmic solution |
| |
| Pred Forte |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Aqueous Humor Prednisolone Acetate Concentration | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISTA Pharmaceuticals, Inc. | Irvine | California | 92618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | T-Pred | Tobramycin prednisolone acetate combination T-PRED: sterile ophthalmic solution |
| FG001 | Pred Forte | Prednisolone acetate Pred Forte: sterile ophthalmic solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | T-Pred | Tobramycin prednisolone acetate combination T-PRED: sterile ophthalmic solution |
| BG001 | Pred Forte | Prednisolone acetate Pred Forte: sterile ophthalmic solution |
| 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 | Mean Aqueous Humor Prednisolone Acetate Concentration | Analysis Population was defined as all participants who received investigational product and on whom successful anterior chamber tap were performed at the designated time point | Posted | Mean | Standard Deviation | ng/mL | 4 hours |
|
4 hours
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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 | T-Pred | Tobramycin prednisolone acetate combination T-PRED: sterile ophthalmic solution at the first time point Pred Forte: sterile ophthalmic solution at the first time point |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | susan.harris@bauschhealth.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C009935 | prednisolone acetate |
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| Drug |
Pred Forte sterile ophthalmic solution |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Pred Forte | Prednisolone acetate T-PRED: sterile ophthalmic solution at the second time point Pred Forte: sterile ophthalmic solution at the second time point | 0 | 32 | 0 | 32 | 0 | 32 |
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