Trial Outcomes & Findings for ESBA105 in Patients With Severe Dry Eye (NCT NCT01338610)
NCT ID: NCT01338610
Last Updated: 2013-04-19
Results Overview
An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).
COMPLETED
PHASE2
334 participants
Up to 28 days
2013-04-19
Participant Flow
Subjects were recruited from 16 investigative sites located within the United States. Participant flow data is presented for all subjects exposed to product.
Of the 334 enrolled, 210 subjects did not qualify for Run-In and were exited from the study without exposure to product. Of the 124 entering Run-In, 39 did not qualify for treatment. The 85 subjects qualifying for treatment were randomized 2:1 to receive either ESBA105 or Vehicle.
Participant milestones
| Measure |
Run-In Only
ESBA105 vehicle
|
ESBA105
ESBA105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
|
Vehicle
ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
56
|
29
|
|
Overall Study
COMPLETED
|
34
|
55
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
1
|
Reasons for withdrawal
| Measure |
Run-In Only
ESBA105 vehicle
|
ESBA105
ESBA105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
|
Vehicle
ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
|
|---|---|---|---|
|
Overall Study
Patient Decision Unrelated to Advs Event
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
3
|
0
|
0
|
Baseline Characteristics
ESBA105 in Patients With Severe Dry Eye
Baseline characteristics by cohort
| Measure |
Run-In Only
n=39 Participants
ESBA105 vehicle
|
ESBA105
n=56 Participants
ESBA 105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
|
Vehicle
n=29 Participants
ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<65
|
24 participants
n=5 Participants
|
32 participants
n=7 Participants
|
21 participants
n=5 Participants
|
77 participants
n=4 Participants
|
|
Age, Customized
≥65
|
15 participants
n=5 Participants
|
24 participants
n=7 Participants
|
8 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
56 participants
n=7 Participants
|
29 participants
n=5 Participants
|
124 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: All subjects randomized to treatment and receiving at least 1 administration of study medication (intent-to-treat). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.
An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).
Outcome measures
| Measure |
ESBA105
n=56 Participants
ESBA105 ophthalmic solution
|
Vehicle
n=29 Participants
ESBA105 vehicle
|
|---|---|---|
|
Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28
|
63.8773 Units on a scale x days
Standard Error 2.4832
|
70.2194 Units on a scale x days
Standard Error 2.39802
|
Adverse Events
Run-In
ESBA105
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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