Trial Outcomes & Findings for Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery (NCT NCT00645671)
NCT ID: NCT00645671
Last Updated: 2015-03-24
Results Overview
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
400 participants
Primary outcome timeframe
Postoperative Day 8 (Visit 5)
Results posted on
2015-03-24
Participant Flow
A total of 400 subjects, 18 years old or older who were candidates for routine, uncomplicated cataract surgery, were enrolled at 17 investigative sites in the US. First subject was enrolled on 3/14/2008 and last subject visit was 3/23/2009.
Following cataract surgery at visit 3 (post operative day 1), subjects were assessed for eligibility. 201 subjects were randomized to receive loteprednol etabonate ointment and 199 to receive its vehicle.
Participant milestones
| Measure |
Loteprednol Etabonate
Loteprednol etabonate 0.5% ophthalmic ointment
|
Vehicle
Vehicle of loteprednol etabonate ointment
|
|---|---|---|
|
Overall Study
STARTED
|
201
|
199
|
|
Overall Study
COMPLETED
|
200
|
193
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
Loteprednol Etabonate
Loteprednol etabonate 0.5% ophthalmic ointment
|
Vehicle
Vehicle of loteprednol etabonate ointment
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery
Baseline characteristics by cohort
| Measure |
Loteprednol Etabonate
n=201 Participants
Loteprednol etabonate 0.5% ophthalmic ointment
|
Vehicle
n=199 Participants
Vehicle of loteprednol etabonate ointment
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 9.39 • n=99 Participants
|
69.2 years
STANDARD_DEVIATION 8.77 • n=107 Participants
|
69.2 years
STANDARD_DEVIATION 9.08 • n=206 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
237 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
6 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 participants
n=99 Participants
|
12 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
183 participants
n=99 Participants
|
179 participants
n=107 Participants
|
362 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Postoperative Day 8 (Visit 5)Population: Intent to treat population
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Outcome measures
| Measure |
Loteprednol Etabonate
n=201 Participants
Loteprednol etabonate 0.5% ophthalmic ointment
|
Vehicle
n=199 Participants
Vehicle of loteprednol etabonate ointment
|
|---|---|---|
|
Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0.
No
|
153 participants
|
172 participants
|
|
Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0.
Yes
|
48 participants
|
27 participants
|
PRIMARY outcome
Timeframe: Postoperative Day 8 (Visit 5)Population: Intent to treat population
Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe
Outcome measures
| Measure |
Loteprednol Etabonate
n=201 Participants
Loteprednol etabonate 0.5% ophthalmic ointment
|
Vehicle
n=199 Participants
Vehicle of loteprednol etabonate ointment
|
|---|---|---|
|
Grade 0 for Pain
Yes
|
156 participants
|
90 participants
|
|
Grade 0 for Pain
No
|
45 participants
|
109 participants
|
SECONDARY outcome
Timeframe: At each follow-up visit through day18 (Visit 7)Population: Intent to treat population
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Outcome measures
| Measure |
Loteprednol Etabonate
n=201 Participants
Loteprednol etabonate 0.5% ophthalmic ointment
|
Vehicle
n=199 Participants
Vehicle of loteprednol etabonate ointment
|
|---|---|---|
|
Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.
Visit 4 (postoperative day 3)
|
10 participants
|
9 participants
|
|
Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.
Visit 5 (postoperative day 8)
|
48 participants
|
27 participants
|
|
Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.
Visit 6 (postoperative day 15)
|
84 participants
|
30 participants
|
|
Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.
Visit 7 (postoperative day 18)
|
86 participants
|
39 participants
|
SECONDARY outcome
Timeframe: Baseline and each follow-up visit through day18 (Visit 7)Population: Intent to treat population
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Outcome measures
| Measure |
Loteprednol Etabonate
n=201 Participants
Loteprednol etabonate 0.5% ophthalmic ointment
|
Vehicle
n=199 Participants
Vehicle of loteprednol etabonate ointment
|
|---|---|---|
|
Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
Visit 4 (postoperative day 3)
|
-1.0 Composit scores
Standard Deviation 1.08
|
-0.4 Composit scores
Standard Deviation 1.42
|
|
Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
Visit 5 (postoperative day 8)
|
-2.1 Composit scores
Standard Deviation 1.31
|
-0.7 Composit scores
Standard Deviation 1.81
|
|
Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
Visit 6 (postoperative day 15)
|
-2.6 Composit scores
Standard Deviation 1.37
|
-0.9 Composit scores
Standard Deviation 1.97
|
|
Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
Visit 7 (postoperative day 18)
|
-2.5 Composit scores
Standard Deviation 1.45
|
-1.1 Composit scores
Standard Deviation 1.95
|
Adverse Events
Loteprednol Etabonate
Serious events: 3 serious events
Other events: 110 other events
Deaths: 0 deaths
Vehicle
Serious events: 2 serious events
Other events: 161 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Loteprednol Etabonate
n=201 participants at risk
Loteprednol etabonate 0.5% ophthalmic ointment
|
Vehicle
n=199 participants at risk
Vehicle of loteprednol etabonate ointment
|
|---|---|---|
|
Eye disorders
Endophthalmitis
|
0.50%
1/201 • Number of events 1 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
0.50%
1/199 • Number of events 1 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.50%
1/201 • Number of events 1 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
0.50%
1/199 • Number of events 1 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
|
Cardiac disorders
Myocardial Infarction
|
0.50%
1/201 • Number of events 2 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
0.50%
1/199 • Number of events 2 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
|
Eye disorders
Post-operative inflammation
|
0.50%
1/201 • Number of events 1 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
0.50%
1/199 • Number of events 1 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
Other adverse events
| Measure |
Loteprednol Etabonate
n=201 participants at risk
Loteprednol etabonate 0.5% ophthalmic ointment
|
Vehicle
n=199 participants at risk
Vehicle of loteprednol etabonate ointment
|
|---|---|---|
|
Eye disorders
Anterior chamber cell
|
2.5%
5/201 • Number of events 15 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
5.0%
10/199 • Number of events 15 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
|
Eye disorders
Anterior chamber inflammation
|
30.3%
61/201 • Number of events 167 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
53.3%
106/199 • Number of events 167 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
|
Eye disorders
Ciliary hyperemia
|
2.5%
5/201 • Number of events 15 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
5.0%
10/199 • Number of events 15 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
|
Eye disorders
Conjunctival hyperemia
|
5.0%
10/201 • Number of events 25 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
7.5%
15/199 • Number of events 25 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
|
Eye disorders
Corneal edema
|
4.0%
8/201 • Number of events 19 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
5.5%
11/199 • Number of events 19 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
|
Eye disorders
Eye pain
|
4.0%
8/201 • Number of events 34 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
13.1%
26/199 • Number of events 34 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
|
Eye disorders
Iritis
|
5.5%
11/201 • Number of events 30 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
9.5%
19/199 • Number of events 30 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
|
Eye disorders
Lacrimation increased
|
3.0%
6/201 • Number of events 20 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
7.0%
14/199 • Number of events 20 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
|
Eye disorders
Ocular hyperemia
|
2.5%
5/201 • Number of events 15 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
5.0%
10/199 • Number of events 15 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
|
Eye disorders
Ocular pruritis
|
2.5%
5/201 • Number of events 21 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
8.0%
16/199 • Number of events 21 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
|
Eye disorders
Photophobia
|
8.5%
17/201 • Number of events 36 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
9.5%
19/199 • Number of events 36 • The LE treatment group had a mean exposure of 13.2 days (+/-3.06), the vehicle treatment group mean exposure was 9.2 days (+/-5.10). Mean days of exposure was < 14 days due to the use of rescue medication, especially in the vehicle group.
Ocular AE's in study eyes and were reported prior to rescue medication use - safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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. Prior to publication or presentation, a copy of the final text should be forwarded by the Investigator(s) to the Sponsor or its designee for comment.
- Publication restrictions are in place
Restriction type: OTHER