Trial Outcomes & Findings for Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency (NCT NCT01688726)
NCT ID: NCT01688726
Last Updated: 2018-06-29
Results Overview
The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.
COMPLETED
NA
91 participants
Month 1
2018-06-29
Participant Flow
Participants were recruited from 1 clinical site located in the UK.
A total of 91 participants were enrolled and randomized. This reporting group includes all randomized participants (91).
Participant milestones
| Measure |
SYSTANE BALANCE
One drop 4 times a day for a continuous period of 1 month
|
Minims Saline
One drop 4 times a day for a continuous period of 1 month
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
45
|
|
Overall Study
COMPLETED
|
45
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
SYSTANE BALANCE
One drop 4 times a day for a continuous period of 1 month
|
Minims Saline
One drop 4 times a day for a continuous period of 1 month
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Relocated abroad
|
0
|
1
|
Baseline Characteristics
Evaluation of SYSTANE® BALANCE in Dry Eye Subjects With Lipid Deficiency
Baseline characteristics by cohort
| Measure |
SYSTANE BALANCE
n=46 Participants
One drop 4 times a day for a continuous period of 1 month
|
Minims Saline
n=45 Participants
One drop 4 times a day for a continuous period of 1 month
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 16.51 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 14.84 • n=7 Participants
|
45.7 years
STANDARD_DEVIATION 15.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.
The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.
Outcome measures
| Measure |
SYSTANE BALANCE
n=45 Participants
One drop 4 times a day for a continuous period of 1 month
|
Minims Saline
n=44 Participants
One drop 4 times a day for a continuous period of 1 month
|
Minims Saline/Right Eye
One drop 4 times a day for 1 month
|
Minims Saline/Left Eye
One drop 4 times a day for 1 month
|
|---|---|---|---|---|
|
Mean Bulbar Conjunctival Staining
Right eye
|
0.743 percentage of staining
Standard Deviation 1.685
|
0.442 percentage of staining
Standard Deviation 0.999
|
—
|
—
|
|
Mean Bulbar Conjunctival Staining
Left eye
|
0.531 percentage of staining
Standard Deviation 1.056
|
0.443 percentage of staining
Standard Deviation 1.404
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 1Population: This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.
TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
Outcome measures
| Measure |
SYSTANE BALANCE
n=45 Participants
One drop 4 times a day for a continuous period of 1 month
|
Minims Saline
n=44 Participants
One drop 4 times a day for a continuous period of 1 month
|
Minims Saline/Right Eye
One drop 4 times a day for 1 month
|
Minims Saline/Left Eye
One drop 4 times a day for 1 month
|
|---|---|---|---|---|
|
High Contrast logMAR Time Controlled Visual Acuity (TCVA)
Baseline
|
0.220 logMAR
Standard Deviation 1.105
|
0.253 logMAR
Standard Deviation 0.100
|
—
|
—
|
|
High Contrast logMAR Time Controlled Visual Acuity (TCVA)
60 minutes
|
0.206 logMAR
Standard Deviation 1.106
|
0.295 logMAR
Standard Deviation 0.840
|
—
|
—
|
|
High Contrast logMAR Time Controlled Visual Acuity (TCVA)
90 minutes
|
0.240 logMAR
Standard Deviation 1.124
|
0.202 logMAR
Standard Deviation 0.826
|
—
|
—
|
|
High Contrast logMAR Time Controlled Visual Acuity (TCVA)
120 minutes
|
0.293 logMAR
Standard Deviation 1.090
|
0.206 logMAR
Standard Deviation 0.973
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 1Population: This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment. Here, n represents the number of participants with non-missing values at the specific time point for each arm group, respectively.
NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.
Outcome measures
| Measure |
SYSTANE BALANCE
n=45 Participants
One drop 4 times a day for a continuous period of 1 month
|
Minims Saline
n=45 Participants
One drop 4 times a day for a continuous period of 1 month
|
Minims Saline/Right Eye
n=44 Participants
One drop 4 times a day for 1 month
|
Minims Saline/Left Eye
n=44 Participants
One drop 4 times a day for 1 month
|
|---|---|---|---|---|
|
Non Invasive Tear Film Break-up-time (NIBUT)
Baseline (n=44,44)
|
9.39 seconds
Standard Deviation 7.68
|
7.47 seconds
Standard Deviation 7.38
|
9.53 seconds
Standard Deviation 13.19
|
7.66 seconds
Standard Deviation 8.32
|
|
Non Invasive Tear Film Break-up-time (NIBUT)
120 minutes (n=44,43)
|
6.92 seconds
Standard Deviation 6.52
|
7.26 seconds
Standard Deviation 6.71
|
8.63 seconds
Standard Deviation 10.08
|
6.16 seconds
Standard Deviation 6.59
|
|
Non Invasive Tear Film Break-up-time (NIBUT)
60 minutes (n=44,43)
|
7.81 seconds
Standard Deviation 10.17
|
8.74 seconds
Standard Deviation 10.42
|
8.17 seconds
Standard Deviation 10.45
|
6.96 seconds
Standard Deviation 6.16
|
|
Non Invasive Tear Film Break-up-time (NIBUT)
90 minutes (n=44,43)
|
8.41 seconds
Standard Deviation 9.55
|
7.59 seconds
Standard Deviation 9.64
|
7.31 seconds
Standard Deviation 8.33
|
6.97 seconds
Standard Deviation 5.39
|
Adverse Events
SYSTANE BALANCE
Minims Saline
Serious adverse events
| Measure |
SYSTANE BALANCE
n=46 participants at risk
One drop 4 times a day for a continuous period of 1 month
|
Minims Saline
n=45 participants at risk
One drop 4 times a day for a continuous period of 1 month
|
|---|---|---|
|
Infections and infestations
Blood poisoning
|
2.2%
1/46 • Adverse events (AEs) were collected for the duration of the study (Dec2012 to Nov2013). This analysis population includes all subjects who were randomized into the study, used at least 1 eye drop, and completed at least 1 post-treatment safety assessment.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.
|
0.00%
0/45 • Adverse events (AEs) were collected for the duration of the study (Dec2012 to Nov2013). This analysis population includes all subjects who were randomized into the study, used at least 1 eye drop, and completed at least 1 post-treatment safety assessment.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/46 • Adverse events (AEs) were collected for the duration of the study (Dec2012 to Nov2013). This analysis population includes all subjects who were randomized into the study, used at least 1 eye drop, and completed at least 1 post-treatment safety assessment.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.
|
2.2%
1/45 • Adverse events (AEs) were collected for the duration of the study (Dec2012 to Nov2013). This analysis population includes all subjects who were randomized into the study, used at least 1 eye drop, and completed at least 1 post-treatment safety assessment.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.
|
Other adverse events
Adverse event data not reported
Additional Information
Abayomi Ogundele, Global Brand Medical Affairs Lead
Alcon Research, Ltd.
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