Trial Outcomes & Findings for Clinical Outcomes Following Treatment With SYSTANE® BALANCE (NCT NCT02776670)
NCT ID: NCT02776670
Last Updated: 2019-06-19
Results Overview
TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
308 participants
Primary outcome timeframe
Baseline (Day 0), Day 35
Results posted on
2019-06-19
Participant Flow
Subjects were recruited from 14 study centers located in Australia (2), Taiwan (1), Singapore (1), United Kingdom (1) and the US (9).
Of the 308 enrolled, 77 were exited as screen failures prior to randomization. This reporting group includes all randomized and treated subjects (231).
Participant milestones
| Measure |
SYSTANE BALANCE
Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
|
REFRESH OPTIVE
Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
114
|
|
Overall Study
Full Analysis Set (FAS)
|
117
|
114
|
|
Overall Study
Per Protocol Analysis Set (PPS)
|
115
|
113
|
|
Overall Study
Safety Analysis Set
|
117
|
114
|
|
Overall Study
COMPLETED
|
117
|
108
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
SYSTANE BALANCE
Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
|
REFRESH OPTIVE
Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Other - Reason not given
|
0
|
1
|
Baseline Characteristics
Clinical Outcomes Following Treatment With SYSTANE® BALANCE
Baseline characteristics by cohort
| Measure |
SYSTANE BALANCE
n=117 Participants
Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
|
REFRESH OPTIVE
n=114 Participants
Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days
|
Total
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.7 years
STANDARD_DEVIATION 14.70 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 16.35 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 15.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
81 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Day 35Population: Per Protocol Analysis Set. At each time point, only subjects with a value at both Baseline and that time point are included.
TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.
Outcome measures
| Measure |
SYSTANE BALANCE
n=115 Participants
Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
|
REFRESH OPTIVE
n=110 Participants
Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days
|
|---|---|---|
|
Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35
|
0.999 seconds
Standard Deviation 1.9439
|
0.864 seconds
Standard Deviation 1.6198
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 35Population: Full Analysis Set. At each time point, only subjects with a value at both Baseline and that time point are included.
TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.
Outcome measures
| Measure |
SYSTANE BALANCE
n=117 Participants
Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
|
REFRESH OPTIVE
n=110 Participants
Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days
|
|---|---|---|
|
Change From Baseline in TFBUT at Day 35
|
0.985 seconds
Standard Error 0.1651
|
0.867 seconds
Standard Error 0.1702
|
SECONDARY outcome
Timeframe: Day 35Population: Area under the curve (AUC) lipid layer thickness (LLT) was removed from formal analysis as a secondary endpoint via amendment of the standalone Statistical Analysis Plan (SAP) due to a large proportion of data that were above the limit of detection.
LLT was measured using the LipiView® Ocular Surface Interferometer, an ophthalmic imaging device intended for use in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. Using these images, the LipiView® Interferometer measures the absolute thickness of the tear film lipid layer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 35Population: Full Analysis Set. At each time point, only subjects with a value at both Baseline and that time point are included.
Ocular discomfort frequency and severity (each graded on a separate 100-units scale) were assessed using a visual analog scale (VAS). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past week' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past week' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for the given visit, as the square root of the product of the ocular discomfort frequency score multiplied by the ocular discomfort severity score. Improvement results in a reduction of the ocular discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
SYSTANE BALANCE
n=117 Participants
Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days
|
REFRESH OPTIVE
n=110 Participants
Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days
|
|---|---|---|
|
Mean Change From Baseline in Global Ocular Discomfort Visual Analog Scale (VAS) Score at Day 35
|
-9.9 units on a scale
Standard Deviation 25.26
|
-8.8 units on a scale
Standard Deviation 26.11
|
Adverse Events
SYSTANE BALANCE
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
REFRESH OPTIVE
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SYSTANE BALANCE
n=117 participants at risk
All subjects exposed to SYSTANE® BALANCE
|
REFRESH OPTIVE
n=114 participants at risk
All subjects exposed to REFRESH OPTIVE®
|
|---|---|---|
|
Infections and infestations
Abscess neck
|
0.00%
0/117 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
0.88%
1/114 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
Other adverse events
| Measure |
SYSTANE BALANCE
n=117 participants at risk
All subjects exposed to SYSTANE® BALANCE
|
REFRESH OPTIVE
n=114 participants at risk
All subjects exposed to REFRESH OPTIVE®
|
|---|---|---|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.85%
1/117 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
3.5%
4/114 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.85%
1/117 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
2.6%
3/114 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
|
Eye disorders
Eye irritation
|
1.7%
2/117 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
0.00%
0/114 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
|
Eye disorders
Eye pain
|
0.00%
0/117 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
2.6%
3/114 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/117 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
1.8%
2/114 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
|
Infections and infestations
Sinusitis
|
0.85%
1/117 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
2.6%
3/114 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
|
Investigations
Vital dye staining cornea present
|
1.7%
2/117 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
0.00%
0/114 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/117 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
1.8%
2/114 • Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
|
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