Trial Outcomes & Findings for Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery (NCT NCT01010633)
NCT ID: NCT01010633
Last Updated: 2012-01-09
Results Overview
Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
COMPLETED
PHASE3
406 participants
Visit 5 (Postoperative day 8)
2012-01-09
Participant Flow
This study was initiated at 20 clinics in the United States (US). Three sites did not enroll any participants. The study was conducted at the remaining 17 sites. First participant was enrolled 11/23/2009 and last participant completed 6/25/2010.
406 participants eligible for cataract surgery were enrolled in the study (safety population). 397 participants completed the study.
Participant milestones
| Measure |
Loteprednol
Loteprednol etabonate 0.5%
|
Vehicle
Vehicle of loteprednol etabonate
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
203
|
|
Overall Study
COMPLETED
|
199
|
198
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Loteprednol
Loteprednol etabonate 0.5%
|
Vehicle
Vehicle of loteprednol etabonate
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Investigator decision
|
0
|
1
|
Baseline Characteristics
Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Baseline characteristics by cohort
| Measure |
Loteprednol
n=203 Participants
Loteprednol etabonate 0.5%
|
Vehicle
n=203 Participants
Vehicle of loteprednol etabonate
|
Total
n=406 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
69.3 years
STANDARD_DEVIATION 8.73 • n=99 Participants
|
69.0 years
STANDARD_DEVIATION 9.80 • n=107 Participants
|
69.1 years
STANDARD_DEVIATION 9.27 • n=206 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
231 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
175 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
20 participants
n=99 Participants
|
16 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
176 participants
n=99 Participants
|
182 participants
n=107 Participants
|
358 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=99 Participants
|
1 participants
n=107 Participants
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Visit 5 (Postoperative day 8)Population: Intent to treat (ITT) population
Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
Outcome measures
| Measure |
Loteprednol
n=203 Eyes
Loteprednol Etabonate 0.5%
|
Vehicle
n=203 Eyes
Vehicle of Loteprednol Etabonate
|
|---|---|---|
|
Resolution of Anterior Chamber Cells (ACC).
|
62 Eyes
|
33 Eyes
|
PRIMARY outcome
Timeframe: Visit 5 (Postoperative Day 8)Population: Intent to treat population (ITT)
Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.
Outcome measures
| Measure |
Loteprednol
n=203 Eyes
Loteprednol Etabonate 0.5%
|
Vehicle
n=203 Eyes
Vehicle of Loteprednol Etabonate
|
|---|---|---|
|
Grade 0 Pain
|
148 Eyes
|
85 Eyes
|
SECONDARY outcome
Timeframe: At visits 4-7- postoperative day 3, 8,15 & 18Study eyes with complete resolution of anterior chamber cells (ACC)
Outcome measures
| Measure |
Loteprednol
n=203 Participants
Loteprednol Etabonate 0.5%
|
Vehicle
n=203 Participants
Vehicle of Loteprednol Etabonate
|
|---|---|---|
|
Resolution of Anterior Chamber Cells.
Visit 5
|
62 Eyes
|
33 Eyes
|
|
Resolution of Anterior Chamber Cells.
Visit 4
|
17 Eyes
|
11 Eyes
|
|
Resolution of Anterior Chamber Cells.
Visit 6
|
102 Eyes
|
44 Eyes
|
|
Resolution of Anterior Chamber Cells.
Visit 7
|
96 Eyes
|
45 Eyes
|
Adverse Events
Loteprednol
Vehicle
Serious adverse events
| Measure |
Loteprednol
n=203 participants at risk
Loteprednol etabonate 0.5%
|
Vehicle
n=203 participants at risk
Vehicle of loteprednol etabonate
|
|---|---|---|
|
Eye disorders
Cystoid Macular Edema
|
0.49%
1/203 • Number of events 1 • Visit 3 post-operative day 1 thru visit 7 postoperative day 18
|
0.49%
1/203 • Number of events 1 • Visit 3 post-operative day 1 thru visit 7 postoperative day 18
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/203 • Visit 3 post-operative day 1 thru visit 7 postoperative day 18
|
0.49%
1/203 • Number of events 1 • Visit 3 post-operative day 1 thru visit 7 postoperative day 18
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/203 • Visit 3 post-operative day 1 thru visit 7 postoperative day 18
|
0.49%
1/203 • Number of events 1 • Visit 3 post-operative day 1 thru visit 7 postoperative day 18
|
Other adverse events
Adverse event data not reported
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