Trial Outcomes & Findings for Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye (NCT NCT02446015)
NCT ID: NCT02446015
Last Updated: 2018-07-02
Results Overview
The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is "Absent" and 5 is "Severe." The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
COMPLETED
NA
159 participants
Baseline (Day 0), Day 28
2018-07-02
Participant Flow
Subjects were recruited from 6 study centers located in the US and 2 study centers located in Australia.
Of the 159 enrolled, 58 subjects were exited as screen failures prior to randomization. An additional 4 subjects were randomized in error and did not receive investigational product (IP). This reporting group includes all treated subjects (97).
Participant milestones
| Measure |
Systane Ultra QID
SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days
|
Systane Ultra PRN
SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
63
|
|
Overall Study
COMPLETED
|
33
|
62
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Systane Ultra QID
SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days
|
Systane Ultra PRN
SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye
Baseline characteristics by cohort
| Measure |
Systane Ultra QID
n=34 Participants
SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
|
Systane Ultra PRN
n=63 Participants
SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
52.2 years
STANDARD_DEVIATION 18.1 • n=7 Participants
|
50.4 years
STANDARD_DEVIATION 17.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Total Ocular Surface Staining (TOSS) Score
|
5.1 units on a scale
STANDARD_DEVIATION 1.28 • n=5 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 1.07 • n=7 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 1.14 • n=5 Participants
|
|
Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score
|
43.20 units on a scale
STANDARD_DEVIATION 11.049 • n=5 Participants
|
46.75 units on a scale
STANDARD_DEVIATION 9.854 • n=7 Participants
|
45.50 units on a scale
STANDARD_DEVIATION 10.372 • n=5 Participants
|
|
IDEEL Treatment Satisfaction Scores
Effectiveness
|
57.17 units on a scale
STANDARD_DEVIATION 20.708 • n=5 Participants
|
57.54 units on a scale
STANDARD_DEVIATION 20.428 • n=7 Participants
|
57.41 units on a scale
STANDARD_DEVIATION 20.419 • n=5 Participants
|
|
IDEEL Treatment Satisfaction Scores
Inconvenience
|
84.38 units on a scale
STANDARD_DEVIATION 15.329 • n=5 Participants
|
84.03 units on a scale
STANDARD_DEVIATION 14.189 • n=7 Participants
|
84.15 units on a scale
STANDARD_DEVIATION 14.520 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Day 28Population: Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.
The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is "Absent" and 5 is "Severe." The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
Outcome measures
| Measure |
Systane Ultra QID
n=33 Participants
SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
|
Systane Ultra PRN
n=62 Participants
SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
|
|---|---|---|
|
Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28
|
-1.19 units on a scale
Standard Error 0.26
|
-0.94 units on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28Population: Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.
The IDEEL SB module is a 20 question patient reported outcome questionnaire that assesses the subject's symptoms of dry eye. An overall resultant calculated score ranges from 0 to 100, with higher scores indicating greater symptom bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
Outcome measures
| Measure |
Systane Ultra QID
n=33 Participants
SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
|
Systane Ultra PRN
n=62 Participants
SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
|
|---|---|---|
|
Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28
|
-7.00 units on a scale
Standard Error 2.01
|
-2.94 units on a scale
Standard Error 1.85
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 28Population: Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.
The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use (Treatment Effectiveness and Treatment Inconvenience). A resultant overall 0-100 treatment satisfaction score was calculated separately for Treatment Effectiveness and Treatment Inconvenience, with higher scores indicating greater satisfaction and less treatment-related bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
Outcome measures
| Measure |
Systane Ultra QID
n=33 Participants
SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
|
Systane Ultra PRN
n=62 Participants
SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
|
|---|---|---|
|
Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28
Effectiveness
|
2.43 units on a scale
Standard Error 3.53
|
0.16 units on a scale
Standard Error 3.21
|
|
Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28
Inconvenience
|
-11.56 units on a scale
Standard Error 2.94
|
-2.77 units on a scale
Standard Error 2.67
|
Adverse Events
Pretreatment
Systane Ultra QID
Systane Ultra PRN
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
WW Medical Affairs Director, GMA Ophthalmics
Alcon, A Novartis Division
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