Trial Outcomes & Findings for Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery (NCT NCT01060072)
NCT ID: NCT01060072
Last Updated: 2012-01-13
Results Overview
Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
407 participants
Primary outcome timeframe
Visit 5 (Postoperative day 8)
Results posted on
2012-01-13
Participant Flow
This study was conducted at 22 enrolling sites; 2 in the European Union (EU) and 20 in the United States (US). First participant was enrolled on 2/19/2010 and last participant completed the study on 9/3/2010.
A total of 407 participants, who were candidates for routine, uncomplicated cataract surgery, were enrolled in the study, 400 participants completed the study.
Participant milestones
| Measure |
Loteprednol Etabonate
Loteprednol etabonate 0.5% ophthalmic suspension
|
Vehicle
Vehicle of loteprednol etabonate ophthalmic suspension.
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
201
|
|
Overall Study
COMPLETED
|
204
|
196
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Loteprednol Etabonate
Loteprednol etabonate 0.5% ophthalmic suspension
|
Vehicle
Vehicle of loteprednol etabonate ophthalmic suspension.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Acute cholecystitis
|
1
|
0
|
|
Overall Study
Excluded Medications
|
0
|
1
|
Baseline Characteristics
Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Baseline characteristics by cohort
| Measure |
Loteprednol Etabonate
n=206 Participants
Loteprednol etabonate 0.5% ophthalmic suspension
|
Vehicle
n=201 Participants
Vehicle of loteprednol etabonate ophthalmic suspension.
|
Total
n=407 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
68.3 years
STANDARD_DEVIATION 9.66 • n=5 Participants
|
69.4 years
STANDARD_DEVIATION 9.56 • n=7 Participants
|
68.9 years
STANDARD_DEVIATION 9.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
198 participants
n=5 Participants
|
193 participants
n=7 Participants
|
391 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 5 (Postoperative day 8)Population: Intention to treat (ITT) population
Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells
Outcome measures
| Measure |
Loteprednol Etabonate
n=206 Participants
Loteprednol etabonate 0.5% ophthalmic suspension
|
Vehicle
n=201 Participants
Vehicle of loteprednol etabonate ophthalmic suspension.
|
|---|---|---|
|
Resolution of Anterior Chamber Cells.
|
64 participants
|
28 participants
|
PRIMARY outcome
Timeframe: Visit 5 (Postoperative day 8)Population: Intention to treat (ITT) population
Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain
Outcome measures
| Measure |
Loteprednol Etabonate
n=206 Participants
Loteprednol etabonate 0.5% ophthalmic suspension
|
Vehicle
n=201 Participants
Vehicle of loteprednol etabonate ophthalmic suspension.
|
|---|---|---|
|
Grade 0 Pain
|
156 participants
|
92 participants
|
SECONDARY outcome
Timeframe: Visit 4-7 (postoperative day 3-18)Population: Intention to treat population (ITT)
Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells
Outcome measures
| Measure |
Loteprednol Etabonate
n=206 Participants
Loteprednol etabonate 0.5% ophthalmic suspension
|
Vehicle
n=201 Participants
Vehicle of loteprednol etabonate ophthalmic suspension.
|
|---|---|---|
|
Resolution of Anterior Chamber Cells
Visit 4 (Postoperative Day 3)
|
8 participants
|
7 participants
|
|
Resolution of Anterior Chamber Cells
Visit 5 (Postoperative Day 8)
|
64 participants
|
28 participants
|
|
Resolution of Anterior Chamber Cells
Visit 6 (Postoperative Day 15)
|
116 participants
|
61 participants
|
|
Resolution of Anterior Chamber Cells
Visit 7 (Postoperative Day 18)
|
114 participants
|
59 participants
|
SECONDARY outcome
Timeframe: Visits 4-7 (Postoperative days 3-18)Population: Intention to treat population (ITT)
Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain
Outcome measures
| Measure |
Loteprednol Etabonate
n=206 Participants
Loteprednol etabonate 0.5% ophthalmic suspension
|
Vehicle
n=201 Participants
Vehicle of loteprednol etabonate ophthalmic suspension.
|
|---|---|---|
|
Grade 0 Pain
Visit 4 (Postoperative Day 3)
|
139 participants
|
93 participants
|
|
Grade 0 Pain
Visit 5 (Postoperative Day 8)
|
156 participants
|
92 participants
|
|
Grade 0 Pain
Visit 6 (Postoperative Day 15)
|
160 participants
|
89 participants
|
|
Grade 0 Pain
Visit 7 (Postoperative Day 18)
|
151 participants
|
79 participants
|
SECONDARY outcome
Timeframe: Visit 4-7 (postoperative day 3-18)Population: Intention to treat population (ITT)
Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.
Outcome measures
| Measure |
Loteprednol Etabonate
n=206 Participants
Loteprednol etabonate 0.5% ophthalmic suspension
|
Vehicle
n=201 Participants
Vehicle of loteprednol etabonate ophthalmic suspension.
|
|---|---|---|
|
Resolution of Anterior Chamber Flare
Visit 4 (Postoperative Day 3)
|
93 participants
|
64 participants
|
|
Resolution of Anterior Chamber Flare
Visit 5 (Postoperative Day 8)
|
134 participants
|
72 participants
|
|
Resolution of Anterior Chamber Flare
Visit 6 (Postoperative Day 15)
|
162 participants
|
90 participants
|
|
Resolution of Anterior Chamber Flare
Visit 7 (Postoperative Day 18)
|
143 participants
|
75 participants
|
Adverse Events
Loteprednol Etabonate
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Vehicle
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Loteprednol Etabonate
n=206 participants at risk
Loteprednol etabonate 0.5% ophthalmic suspension
|
Vehicle
n=201 participants at risk
Vehicle of loteprednol etabonate ophthalmic suspension.
|
|---|---|---|
|
Gastrointestinal disorders
Diverticulitis
|
0.49%
1/206 • Number of events 1 • 14 Days
|
0.00%
0/201 • 14 Days
|
|
Gastrointestinal disorders
Cholecystitis
|
0.49%
1/206 • Number of events 1 • 14 Days
|
0.00%
0/201 • 14 Days
|
|
Cardiac disorders
Myocardial infarction
|
0.49%
1/206 • Number of events 1 • 14 Days
|
0.00%
0/201 • 14 Days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/206 • 14 Days
|
0.50%
1/201 • Number of events 1 • 14 Days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/206 • 14 Days
|
0.50%
1/201 • Number of events 1 • 14 Days
|
Other adverse events
| Measure |
Loteprednol Etabonate
n=206 participants at risk
Loteprednol etabonate 0.5% ophthalmic suspension
|
Vehicle
n=201 participants at risk
Vehicle of loteprednol etabonate ophthalmic suspension.
|
|---|---|---|
|
Eye disorders
Anterior Chamber Inflammation
|
3.4%
7/206 • Number of events 7 • 14 Days
|
7.0%
14/201 • Number of events 14 • 14 Days
|
|
Eye disorders
Eye Pain
|
1.5%
3/206 • Number of events 3 • 14 Days
|
5.0%
10/201 • Number of events 10 • 14 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
- Publication restrictions are in place
Restriction type: OTHER