Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate ophthalmic gel, 0.38% (BID and TID) for the treatment of postoperative inflammation and pain following cataract surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loteprednol Etabonate Gel (BID) | Experimental | Loteprednol Etabonate Gel 0.38% administered two times daily (BID). |
|
| Vehicle (BID) | Active Comparator | Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID). |
|
| Loteprednol Etabonate Gel (TID) | Experimental | Loteprednol Gel 0.38% administered three times daily (TID). |
|
| Vehicle (TID) | Active Comparator | Vehicle of Loteprednol Etabonate Gel 0.38% administered three times daily (TID). |
|
| 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. |
Not provided
Inclusion Criteria:
Visit 1 (Screening Visit)
Visit 3 (Postoperative Day 1)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jon I Williams, PhD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Bridgewater | New Jersey | 08807 | United States |
Not provided
The 2 vehicle arms were combined into 1 treatment group in the statistical analysis, and hence the study has 3 treatment groups (ie, Loteprednol Etabonate Gel TID, Loteprednol Etabonate Gel BID, and [combined] vehicle groups).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle (BID and TID) | Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID) and three times daily (TID), combined arms One drop of vehicle instilled into the study eye two times per day (BID) and three times a day (TID) for 14 days |
| FG001 | Loteprednol Etabonate Gel (BID) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Loteprednol Etabonate Gel (TID) | Drug | One drop of LE gel instilled into the study eye three times per day (TID) for 14 days. |
|
|
| Vehicle (BID) | Drug | One drop of vehicle instilled into the study eye two times per day (BID) for 14 days |
|
|
| Vehicle (TID) | Drug | One drop of vehicle instilled into the study eye three times per day (TID) 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 |
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 |
| FG002 | Loteprednol Etabonate Gel (TID) | Loteprednol Gel 0.38% administered three times daily (TID). Loteprednol Etabonate Gel (TID): One drop of LE gel instilled into the study eye three times per day (TID) for 14 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle (BID and TID) | Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID) and three times daily (TID), combined arms One drop of vehicle instilled into the study eye two times per day (BID) and three times a day (TID) for 14 days |
| BG001 | 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 |
| BG002 | Loteprednol Etabonate Gel (TID) | Loteprednol Gel 0.38% administered three times daily (TID). Loteprednol Etabonate Gel (TID): One drop of LE gel instilled into the study eye three times per day (TID) for 14 days. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 |
|
|
| ||||||||||||||||||||||||||||||||
| 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 |
|
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 513 participants in the safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vehicle (BID and TID) | Vehicle of Loteprednol Etabonate Gel 0.38% administered two times daily (BID) and three times daily (TID), combined arms One drop of vehicle instilled into the study eye two times per day (BID) and three times a day (TID) for 14 days | 0 | 172 | 1 | 172 | 0 | 172 |
| EG001 | 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 | 0 | 171 | 1 | 171 | 0 | 171 |
| EG002 | Loteprednol Etabonate Gel (TID) | Loteprednol Gel 0.38% administered three times daily (TID). Loteprednol Etabonate Gel (TID): One drop of LE gel instilled into the study eye three times per day (TID) for 14 days. | 0 | 170 | 0 | 170 | 0 | 170 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endophthalmitis | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
Not provided
Contact sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | susan.harris@bauschhealth.com |
| 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 |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C494814 | BID protein, human |
| D000069559 | Loteprednol Etabonate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
|
|
Loteprednol Gel 0.38% administered three times daily (TID).
Loteprednol Etabonate Gel (TID): One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.
|
|
|
|
|
|
| OG002 | Loteprednol Etabonate Gel (TID) | Loteprednol Gel 0.38% administered three times daily (TID). Loteprednol Etabonate Gel (TID): One drop of LE gel instilled into the study eye three times per day (TID) for 14 days. |
|
|