Trial Outcomes & Findings for Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery (NCT NCT00699153)
NCT ID: NCT00699153
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
This study was conducted at 16 sites in the US. The first participant was enrolled June 20, 2008 and the last participant visit was May 1, 2009.
405 participants, who were candidates for routine, uncomplicated cataract surgery were enrolled in the study.
Participant milestones
| Measure |
Loteprednol Etabonate
Loteprednol Etabonate Ophthalmic Ointment 0.5%
|
Vehicle
Vehicle of Ophthalmic Loteprednol Etabonate
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
202
|
|
Overall Study
COMPLETED
|
200
|
200
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Loteprednol Etabonate
Loteprednol Etabonate Ophthalmic Ointment 0.5%
|
Vehicle
Vehicle of Ophthalmic Loteprednol Etabonate
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Travel Problem
|
1
|
0
|
Baseline Characteristics
Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
Baseline characteristics by cohort
| Measure |
Loteprednol Etabonate
n=203 Participants
Loteprednol Etabonate Ophthalmic Ointment 0.5%
|
Vehicle
n=202 Participants
Vehicle of Ophthalmic Loteprednol Etabonate
|
Total
n=405 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 9.13 • n=5 Participants
|
69.2 years
STANDARD_DEVIATION 9.36 • n=7 Participants
|
68.8 years
STANDARD_DEVIATION 9.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
182 participants
n=5 Participants
|
178 participants
n=7 Participants
|
360 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawiian/Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperative day 8 (Visit 5)Population: Intent to treat population, subjects who had missing data or took rescue medication prior to visit 5 were imputed as no.
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=203 Participants
Loteprednol Etabonate Ophthalmic Ointment 0.5%
|
Vehicle
n=202 Participants
Vehicle of Ophthalmic Loteprednol Etabonate
|
|---|---|---|
|
Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0
|
64 participants
|
23 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=203 Participants
Loteprednol Etabonate Ophthalmic Ointment 0.5%
|
Vehicle
n=202 Participants
Vehicle of Ophthalmic Loteprednol Etabonate
|
|---|---|---|
|
Participants With Grade 0 (no) Pain
|
149 participants
|
83 participants
|
SECONDARY outcome
Timeframe: At each visit: Visit 4-7, postoperative days 3-18Population: 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=203 Participants
Loteprednol Etabonate Ophthalmic Ointment 0.5%
|
Vehicle
n=202 Participants
Vehicle of Ophthalmic Loteprednol Etabonate
|
|---|---|---|
|
Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.
Visit 4, postoperative day 3
|
10 participants
|
9 participants
|
|
Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.
Visit 5, postoperative day 8
|
64 participants
|
23 participants
|
|
Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.
Visit 6, posoperative day 15
|
107 participants
|
42 participants
|
|
Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.
Visit 7, postoperative day 18
|
100 participants
|
46 participants
|
SECONDARY outcome
Timeframe: Postoperative Day 3-18 (Each follow-up Visit 4-7)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=203 Participants
Loteprednol Etabonate Ophthalmic Ointment 0.5%
|
Vehicle
n=202 Participants
Vehicle of Ophthalmic Loteprednol Etabonate
|
|---|---|---|
|
Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
Visit 4, postoperative day 3
|
-1.2 Composite scores
Standard Deviation 1.20
|
-0.6 Composite scores
Standard Deviation 1.48
|
|
Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
Visit 5, postoperative day 8
|
-2.2 Composite scores
Standard Deviation 1.51
|
-0.8 Composite scores
Standard Deviation 1.81
|
|
Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
Visit 6, postoperative day 15
|
-2.7 Composite scores
Standard Deviation 1.58
|
-1.1 Composite scores
Standard Deviation 1.94
|
|
Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
Visit 7, postoperative day 18
|
-2.6 Composite scores
Standard Deviation 1.59
|
-1.1 Composite scores
Standard Deviation 2.01
|
Adverse Events
Loteprednol Etabonate
Serious events: 2 serious events
Other events: 81 other events
Deaths: 0 deaths
Vehicle
Serious events: 4 serious events
Other events: 151 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Loteprednol Etabonate
n=204 participants at risk
Loteprednol Etabonate Ophthalmic Ointment 0.5%
|
Vehicle
n=201 participants at risk
Vehicle of Ophthalmic Loteprednol Etabonate
|
|---|---|---|
|
Cardiac disorders
Blocked arteries
|
0.98%
2/204 • Number of events 2 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
1.00%
2/201 • Number of events 2 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
|
Endocrine disorders
Diabetic foot ulcer
|
0.49%
1/204 • Number of events 1 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
0.50%
1/201 • Number of events 1 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
|
Musculoskeletal and connective tissue disorders
Fall/Hip fracture
|
0.98%
2/204 • Number of events 2 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
1.00%
2/201 • Number of events 2 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
|
Endocrine disorders
Pituitary tumor
|
0.49%
1/204 • Number of events 1 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
0.50%
1/201 • Number of events 1 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
Other adverse events
| Measure |
Loteprednol Etabonate
n=204 participants at risk
Loteprednol Etabonate Ophthalmic Ointment 0.5%
|
Vehicle
n=201 participants at risk
Vehicle of Ophthalmic Loteprednol Etabonate
|
|---|---|---|
|
Eye disorders
Anterior chamber inflammation
|
24.0%
49/204 • Number of events 119 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
46.8%
94/201 • Number of events 241 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
|
Eye disorders
Eye Pain
|
3.4%
7/204 • Number of events 119 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
8.5%
17/201 • Number of events 241 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
|
Eye disorders
Corneal Edema
|
4.9%
10/204 • Number of events 119 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
6.0%
12/201 • Number of events 241 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
|
Eye disorders
Conjunctival Hyperemia
|
2.9%
6/204 • Number of events 119 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
7.5%
15/201 • Number of events 241 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
|
Eye disorders
Ciliary Hyperemia
|
2.5%
5/204 • Number of events 119 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
6.5%
13/201 • Number of events 241 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
|
Eye disorders
Photophobia
|
2.5%
5/204 • Number of events 119 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
6.0%
12/201 • Number of events 241 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
|
Eye disorders
Iritis
|
2.0%
4/204 • Number of events 119 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
6.0%
12/201 • Number of events 241 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
|
Eye disorders
Uveitis
|
2.0%
4/204 • Number of events 119 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
5.0%
10/201 • Number of events 241 • Following drug administration visit 3 (postoperative day 1) through visit 7 (postoperative day 18).
Ocular treatment related ocular AE's in \>/= 5% of Study Eyes, Either Treatment Group, Prior to Rescue Medication Use - Safety Population 204 Loteptednol, 201 Vehicle.
|
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