Trial Outcomes & Findings for Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (NCT NCT01996839)
NCT ID: NCT01996839
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
514 participants
8 days
2020-09-25
Participant Flow
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).
Participant milestones
| Measure |
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
|
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
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
172
|
171
|
171
|
|
Overall Study
COMPLETED
|
80
|
133
|
139
|
|
Overall Study
NOT COMPLETED
|
92
|
38
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Baseline characteristics by cohort
| Measure |
Vehicle (BID and TID)
n=172 Participants
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
|
Loteprednol Etabonate Gel (BID)
n=171 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
|
Loteprednol Etabonate Gel (TID)
n=171 Participants
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.
|
Total
n=514 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 8.56 • n=5 Participants
|
70.0 years
STANDARD_DEVIATION 8.34 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 8.36 • n=4 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
283 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
231 Participants
n=4 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 |
Vehicle (BID and TID)
n=172 Participants
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
|
Loteprednol Etabonate Gel (BID)
n=171 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
|
Loteprednol Etabonate Gel (TID)
n=171 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
|
16 Participants
|
46 Participants
|
49 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 |
Vehicle (BID and TID)
n=172 Participants
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
|
Loteprednol Etabonate Gel (BID)
n=171 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
|
Loteprednol Etabonate Gel (TID)
n=171 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Grade 0 Pain in the Study Eye.
|
82 Participants
|
126 Participants
|
125 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 |
Vehicle (BID and TID)
n=172 Participants
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
|
Loteprednol Etabonate Gel (BID)
n=171 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
|
Loteprednol Etabonate Gel (TID)
n=171 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
Day 3
|
12 Participants
|
13 Participants
|
7 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
Day 15
|
28 Participants
|
73 Participants
|
83 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit
Day 18
|
40 Participants
|
77 Participants
|
91 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 |
Vehicle (BID and TID)
n=172 Participants
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
|
Loteprednol Etabonate Gel (BID)
n=171 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
|
Loteprednol Etabonate Gel (TID)
n=171 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
Day 3
|
96 Participants
|
123 Participants
|
117 Participants
|
|
Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
Day 15
|
81 Participants
|
129 Participants
|
137 Participants
|
|
Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.
Day 18
|
73 Participants
|
122 Participants
|
122 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 |
Vehicle (BID and TID)
n=172 Participants
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
|
Loteprednol Etabonate Gel (BID)
n=171 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
|
Loteprednol Etabonate Gel (TID)
n=171 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
Day 3
|
78 Participants
|
95 Participants
|
90 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
Day 8
|
71 Participants
|
117 Participants
|
122 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
Day 15
|
71 Participants
|
124 Participants
|
131 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.
Day 18
|
68 Participants
|
115 Participants
|
127 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 |
Vehicle (BID and TID)
n=172 Participants
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
|
Loteprednol Etabonate Gel (BID)
n=171 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
|
Loteprednol Etabonate Gel (TID)
n=171 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
Day 3
|
11 Participants
|
12 Participants
|
7 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
Day 8
|
16 Participants
|
45 Participants
|
47 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
Day 15
|
27 Participants
|
73 Participants
|
83 Participants
|
|
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.
Day 18
|
40 Participants
|
74 Participants
|
90 Participants
|
Adverse Events
Vehicle (BID and TID)
Loteprednol Etabonate Gel (BID)
Loteprednol Etabonate Gel (TID)
Serious adverse events
| Measure |
Vehicle (BID and TID)
n=172 participants at risk
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
|
Loteprednol Etabonate Gel (BID)
n=171 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
|
Loteprednol Etabonate Gel (TID)
n=170 participants at risk
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.
|
|---|---|---|---|
|
Eye disorders
Endophthalmitis
|
0.58%
1/172 • 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.
|
0.00%
0/171 • 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.
|
0.00%
0/170 • 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.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/172 • 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.
|
0.58%
1/171 • 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.
|
0.00%
0/170 • 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.
|
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