Trial Outcomes & Findings for The Effect of BEPREVE 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer (NCT NCT01346371)
NCT ID: NCT01346371
Last Updated: 2020-03-31
Results Overview
The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
56 days after initial screening visit
Results posted on
2020-03-31
Participant Flow
Recruitment began Aug 15, 2011 and concluded June 11, 2012. There are a variety of sources we recruited our subjects from which is outlined below: Email. PI referrals, employee, and subject referrals. Flyers posted around college campuses. Website clinicaltrial.gov.
Participant milestones
| Measure |
Refresh Tears® Eye Drops
Must add drops twice a day every day during trial enrollment.
|
Bepreve® 1.5% Solution
Must add drops twice a day every day while enrolled in trial.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Refresh Tears® Eye Drops
Must add drops twice a day every day during trial enrollment.
|
Bepreve® 1.5% Solution
Must add drops twice a day every day while enrolled in trial.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
The Effect of BEPREVE 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer
Baseline characteristics by cohort
| Measure |
Refresh Tears® Eye Drops
n=20 Participants
Must add drops twice a day every day during trial enrollment.
|
Bepreve® 1.5% Solution
n=20 Participants
Must add drops twice a day every day while enrolled in trial.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 13 • n=5 Participants
|
35 years
STANDARD_DEVIATION 12 • n=7 Participants
|
38 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 56 days after initial screening visitPopulation: Analysis per protocol as ITT and LOCF for all subject eyes.
The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L.
Outcome measures
| Measure |
Refresh Tears® Eye Drops
n=40 Eyes
Must add drops twice a day every day during trial enrollment.
|
Bepreve® 1.5% Solution
n=40 Eyes
Must add drops twice a day every day while enrolled in trial.
|
|---|---|---|
|
Tear Osmolarity
|
303 mOsM/L
Standard Deviation 3.13
|
303 mOsM/L
Standard Deviation 2.57
|
Adverse Events
Refresh Tears® Eye Drops
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Bepreve® 1.5% Solution
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Refresh Tears® Eye Drops
n=20 participants at risk
Must add drops twice a day every day during trial enrollment.
|
Bepreve® 1.5% Solution
n=20 participants at risk
Must add drops twice a day every day while enrolled in trial.
|
|---|---|---|
|
Eye disorders
Ocular Irritation
|
10.0%
2/20 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Ocular Burning
|
25.0%
5/20 • Number of events 5
|
20.0%
4/20 • Number of events 4
|
|
Eye disorders
Ocular itching
|
40.0%
8/20 • Number of events 9
|
35.0%
7/20 • Number of events 7
|
|
General disorders
Cold like symptoms
|
35.0%
7/20 • Number of events 7
|
20.0%
4/20 • Number of events 5
|
|
Gastrointestinal disorders
Stomach problems
|
5.0%
1/20 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Bad Taste in mouth
|
0.00%
0/20
|
35.0%
7/20 • Number of events 7
|
|
Eye disorders
General eye discomfort
|
5.0%
1/20 • Number of events 2
|
5.0%
1/20 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Joint/muscle pain
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place