Trial Outcomes & Findings for Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (NCT NCT02208297)
NCT ID: NCT02208297
Last Updated: 2020-09-25
Results Overview
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.
COMPLETED
PHASE3
326 participants
8 days
2020-09-25
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
163
|
|
Overall Study
COMPLETED
|
141
|
107
|
|
Overall Study
NOT COMPLETED
|
22
|
56
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Baseline characteristics by cohort
| Measure |
Loteprednol Etabonate Gel (BID)
n=163 Participants
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
|
Vehicle Gel (BID)
n=163 Participants
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
|
Total
n=326 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 9.88 • n=93 Participants
|
67.8 years
STANDARD_DEVIATION 8.45 • n=4 Participants
|
67.4 years
STANDARD_DEVIATION 9.19 • n=27 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=93 Participants
|
101 Participants
n=4 Participants
|
190 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
136 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 8 daysPopulation: The analysis population included all randomized participants, with missing values imputed as non-responders.
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.
Outcome measures
| Measure |
Loteprednol Etabonate Gel (BID)
n=163 Participants
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
|
Vehicle Gel (BID)
n=163 Participants
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
|
|---|---|---|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
|
38 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: 8 daysPopulation: The analysis population included all randomized participants, with missing values imputed as non-responders.
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.
Outcome measures
| Measure |
Loteprednol Etabonate Gel (BID)
n=163 Participants
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
|
Vehicle Gel (BID)
n=163 Participants
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
|
|---|---|---|
|
Percentage of Participants With Grade 0 Pain in the Study Eye.
|
120 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: 18 daysPopulation: The analysis population included all randomized participants, with missing values imputed as non-responders.
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.
Outcome measures
| Measure |
Loteprednol Etabonate Gel (BID)
n=163 Participants
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
|
Vehicle Gel (BID)
n=163 Participants
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
|
|---|---|---|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
Day 3
|
16 Participants
|
11 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
Day 15
|
82 Participants
|
57 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
Day 18
|
80 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: 18 daysPopulation: The analysis population included all randomized participants, with missing values imputed as non-responders.
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.
Outcome measures
| Measure |
Loteprednol Etabonate Gel (BID)
n=163 Participants
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
|
Vehicle Gel (BID)
n=163 Participants
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
|
|---|---|---|
|
Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
Day 8
|
106 Participants
|
87 Participants
|
|
Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
Day 15
|
132 Participants
|
95 Participants
|
|
Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
Day 18
|
122 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: 18 daysPopulation: The analysis population included all randomized participants, with missing values imputed as non-responders.
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.
Outcome measures
| Measure |
Loteprednol Etabonate Gel (BID)
n=163 Participants
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
|
Vehicle Gel (BID)
n=163 Participants
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
|
|---|---|---|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
Day 15
|
131 Participants
|
100 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
Day 1
|
96 Participants
|
71 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
Day 8
|
114 Participants
|
81 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
Day 18
|
128 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: 18 daysPopulation: The analysis population included all randomized participants, with missing values imputed as non-responders.
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).
Outcome measures
| Measure |
Loteprednol Etabonate Gel (BID)
n=163 Participants
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
|
Vehicle Gel (BID)
n=163 Participants
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
|
|---|---|---|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
Day 3
|
15 Participants
|
9 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
Day 8
|
37 Participants
|
29 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
Day 15
|
80 Participants
|
56 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
Day 18
|
80 Participants
|
67 Participants
|
Adverse Events
Loteprednol Etabonate Gel (BID)
Vehicle Gel (BID)
Serious adverse events
| Measure |
Loteprednol Etabonate Gel (BID)
n=162 participants at risk
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
|
Vehicle Gel (BID)
n=163 participants at risk
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
|
|---|---|---|
|
Eye disorders
Endophthalmitis
|
0.00%
0/162 • 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.
|
0.61%
1/163 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER