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The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID) for the treatment of inflammation and pain following cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loteprednol Etabonate Gel (BID) | Experimental | Loteprednol Etabonate Gel 0.38% administered two times daily (BID) |
|
| Vehicle Gel (BID) | Placebo Comparator | Vehicle gel administered two times daily (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprednol Etabonate Gel (BID) | Drug | One drop of LE gel instilled into the study eye two times per day (BID) for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells | White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. | 8 days |
| Percentage of Participants With Grade 0 Pain in the Study Eye. | Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe. | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit | White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. |
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Inclusion Criteria:
Visit 1 (Screening Visit)
Visit 3 (Postoperative Day 1)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Vittitow | Valeant/Bausch & Lomb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Bridgewater | New Jersey | 08807 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Loteprednol Etabonate Gel (BID) | Loteprednol Etabonate Gel 0.38% administered two times daily (BID) Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days |
| FG001 | Vehicle Gel (BID) | Vehicle gel administered two times daily (BID) Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Loteprednol Etabonate Gel (BID) | Loteprednol Etabonate Gel 0.38% administered two times daily (BID) Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days |
| BG001 | Vehicle Gel (BID) |
| 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 | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells | White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. | The analysis population included all randomized participants, with missing values imputed as non-responders. | Posted | Count of Participants | Participants | 8 days |
|
18 days
The safety analysis population included all randomized participants who received treatment. There was one participant who did not receive treatment, thus there were 325 participants in the safety population.
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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 | Loteprednol Etabonate Gel (BID) | Loteprednol Etabonate Gel 0.38% administered two times daily (BID) Loteprednol Etabonate Gel (BID): One drop of LE gel instilled into the study eye two times per day (BID) for 14 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endophthalmitis | Eye disorders | MedDRA (16.1) | 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 |
|---|---|
| D007249 | Inflammation |
| D010146 | Pain |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Vehicle Gel (BID) | Drug | One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days |
|
|
| 18 days |
| Percentage of Participants With Grade 0 Pain in the Study Eye by Visit. | White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. | 18 days |
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit. | Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0. | 18 days |
| Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit. | White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). | 18 days |
Vehicle gel administered two times daily (BID) Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Vehicle Gel (BID) | Vehicle gel administered two times daily (BID) Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days |
|
|
| Primary | Percentage of Participants With Grade 0 Pain in the Study Eye. | Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe. | The analysis population included all randomized participants, with missing values imputed as non-responders. | Posted | Count of Participants | Participants | 8 days |
|
|
|
| Secondary | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit | White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. | The analysis population included all randomized participants, with missing values imputed as non-responders. | Posted | Count of Participants | Participants | 18 days |
|
|
|
| Secondary | Percentage of Participants With Grade 0 Pain in the Study Eye by Visit. | White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. | The analysis population included all randomized participants, with missing values imputed as non-responders. | Posted | Count of Participants | Participants | 18 days |
|
|
|
| Secondary | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit. | Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). Complete resolution of AC flare was defined as Grade 0. | The analysis population included all randomized participants, with missing values imputed as non-responders. | Posted | Count of Participants | Participants | 18 days |
|
|
|
| Secondary | Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit. | White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on the 5-point scale, with 0=None (best) and 4=Very Severe (worst). | The analysis population included all randomized participants, with missing values imputed as non-responders. | Posted | Count of Participants | Participants | 18 days |
|
|
|
| 0 |
| 162 |
| 0 |
| 162 |
| 0 |
| 162 |
| EG001 | Vehicle Gel (BID) | Vehicle gel administered two times daily (BID) Vehicle Gel (BID): One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days | 0 | 163 | 1 | 163 | 0 | 163 |
Contact sponsor directly for details.
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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