Trial Outcomes & Findings for Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients (NCT NCT01276223)
NCT ID: NCT01276223
Last Updated: 2013-03-11
Results Overview
A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
722 participants
Primary outcome timeframe
Baseline, up to 4 weeks
Results posted on
2013-03-11
Participant Flow
Subjects were recruited from 25 investigative sites located within the US. Participant flow data is presented for all all subjects exposed to product.
Of the 722 enrolled, 433 subjects did not qualify for Run-In and were exited without exposure to product. Of the 289 entering Run-In, 78 did not qualify for treatment. The 211 patients qualifying for treatment were randomized 1:1 to receive either Durezol or Vehicle.
Participant milestones
| Measure |
Run-In Only
Difluprednate vehicle
|
Durezol
Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment)
|
Vehicle
Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment)
|
|---|---|---|---|
|
Overall Study
STARTED
|
78
|
107
|
104
|
|
Overall Study
COMPLETED
|
67
|
103
|
101
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
3
|
Reasons for withdrawal
| Measure |
Run-In Only
Difluprednate vehicle
|
Durezol
Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment)
|
Vehicle
Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
0
|
1
|
|
Overall Study
Pt Decision Unrelated to Adverse Event
|
3
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients
Baseline characteristics by cohort
| Measure |
Run-In Only
n=78 Participants
Difluprednate vehicle
|
Durezol
n=107 Participants
Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment)
|
Vehicle
n=104 Participants
Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment)
|
Total
n=289 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
61.9 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
60.1 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 14.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
242 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
78 participants
n=5 Participants
|
107 participants
n=7 Participants
|
104 participants
n=5 Participants
|
289 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 4 weeksPopulation: All subjects randomized to treatment and receiving at least 1 administration of study medication (ITT). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.
A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).
Outcome measures
| Measure |
Durezol
n=107 Participants
Difluprednate 0.5% ophthalmic emulsion
|
Vehicle
n=104 Participants
Difluprednate vehicle
|
|---|---|---|
|
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks
Baseline (Week 0)
|
78.3 units on a scale
Standard Deviation 14.4
|
76.8 units on a scale
Standard Deviation 13.8
|
|
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks
Change from Baseline to Week 1
|
-1.1 units on a scale
Standard Deviation 8.8
|
-1.7 units on a scale
Standard Deviation 12.4
|
|
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks
Change from Baseline to Week 2
|
-4.4 units on a scale
Standard Deviation 10.9
|
-4.2 units on a scale
Standard Deviation 14.7
|
|
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks
Change from Baseline to Week 3
|
-4.5 units on a scale
Standard Deviation 13.4
|
-4.8 units on a scale
Standard Deviation 16.2
|
|
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks
Change from Baseline to Week 4
|
-6.2 units on a scale
Standard Deviation 15.1
|
-4.7 units on a scale
Standard Deviation 16.1
|
Adverse Events
Run-In
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Durezol
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Vehicle
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Run-In
n=289 participants at risk
Difluprednate vehicle, all patients
|
Durezol
n=107 participants at risk
Difluprednate 0.05% ophthalmic emulsion
|
Vehicle
n=104 participants at risk
Difluprednate vehicle
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/289 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
0.93%
1/107 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
0.00%
0/104 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/289 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
0.00%
0/107 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
0.96%
1/104 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
Other adverse events
| Measure |
Run-In
n=289 participants at risk
Difluprednate vehicle, all patients
|
Durezol
n=107 participants at risk
Difluprednate 0.05% ophthalmic emulsion
|
Vehicle
n=104 participants at risk
Difluprednate vehicle
|
|---|---|---|---|
|
Eye disorders
Eye pain
|
10.0%
29/289 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
0.93%
1/107 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
1.9%
2/104 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
|
Eye disorders
Eye irritation
|
7.6%
22/289 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
0.93%
1/107 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
1.9%
2/104 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
|
Investigations
Intraocular pressure increased
|
0.35%
1/289 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
9.3%
10/107 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
0.00%
0/104 • Adverse events were collected for the duration of the study (10 months, 15 days).
The safety population includes all subjects exposed to product. Individual subject adverse events, solicited and unsolicited, were collected from time of first instillation of test article (Run-In) until the subject exited the study.
|
Additional Information
Director of Alcon Clinical
Alcon Research
Phone: 1-888-451-3937
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER