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Study of T-PRED(TM) Compared to Pred Forte(R)
This study was a multi-center, randomized, double-masked, bioequivalence study. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point.
The investigator determined which eye was clinically suited for the first operative procedure; treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-Pred | Experimental | Tobramycin prednisolone acetate combination |
|
| Pred Forte | Active Comparator | Prednisolone acetate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-Pred | Drug | sterile ophthalmic solution |
| |
| Pred Forte |
| Measure | Description | Time Frame |
|---|---|---|
| Means Aqueous Humor Prednisolone Acetate Concentration | 35 days |
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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 | All Study Participants | Participants received both treatment groups, one in each eye. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point. The investigator determined which eye was clinically suited for the first operative procedure (surgery); treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned. |
| 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 | Means Aqueous Humor Prednisolone Acetate Concentration | Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned. | Posted | Mean | Standard Deviation | ng/mL | 35 days | eyes | eyes |
|
|
35 days
The safety population was comprised of participants who received study treatment and had at least one post-baseline safety assessment. Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.g
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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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IOL dislocation | Eye disorders | MedDRA 2.0 | Non-systematic Assessment |
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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 |
sterile ophthalmic solution |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
| eyes |
|
|
| 1 |
| 162 |
| 0 |
| 162 |
| EG001 | Pred-Forte | 1 | 162 | 0 | 162 |
| Vitritis | Eye disorders | MedDRA 2.0 | Non-systematic Assessment |
|
Contact sponsor directly for details.