Trial Outcomes & Findings for Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining (NCT NCT01863368)
NCT ID: NCT01863368
Last Updated: 2015-08-04
Results Overview
The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.
COMPLETED
NA
105 participants
Baseline, Day 35
2015-08-04
Participant Flow
Subjects were recruited from 13 study centers located in France and 3 study centers located in Germany.
Of the 105 enrolled, 11 subjects were exited prior to randomization: 9 screen failures, 1 adverse event, and 1 lost to follow-up. This reporting group includes all randomized subjects (94).
Participant milestones
| Measure |
Systane Ultra
Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
Optive
Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
|---|---|---|
|
Phase I, Day 0 to Day 35
STARTED
|
46
|
48
|
|
Phase I, Day 0 to Day 35
Treated
|
46
|
47
|
|
Phase I, Day 0 to Day 35
COMPLETED
|
43
|
41
|
|
Phase I, Day 0 to Day 35
NOT COMPLETED
|
3
|
7
|
|
Phase II, Day 35 to Day 90
STARTED
|
43
|
41
|
|
Phase II, Day 35 to Day 90
COMPLETED
|
41
|
41
|
|
Phase II, Day 35 to Day 90
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Systane Ultra
Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
Optive
Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
|---|---|---|
|
Phase I, Day 0 to Day 35
Adverse Event
|
2
|
4
|
|
Phase I, Day 0 to Day 35
Lost to Follow-up
|
1
|
0
|
|
Phase I, Day 0 to Day 35
Withdrawal by subject prior to treatment
|
0
|
1
|
|
Phase I, Day 0 to Day 35
Withdrawal by Subject
|
0
|
2
|
|
Phase II, Day 35 to Day 90
Adverse Event
|
1
|
0
|
|
Phase II, Day 35 to Day 90
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
Baseline characteristics by cohort
| Measure |
Systane Ultra
n=46 Participants
Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
Optive
n=48 Participants
Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
65.2 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
64.4 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Mean Total Ocular Surface Staining (TOSS) Score
|
5.5 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 35Population: This analysis group includes all randomized subjects with data at visit.
The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Systane Ultra
n=43 Participants
Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
Optive
n=41 Participants
Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
|---|---|---|
|
Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)
|
-2.2 units on a scale
Standard Deviation 2.3
|
-1.7 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Day 35Population: This analysis group includes all subjects with data at visit.
The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.
Outcome measures
| Measure |
Systane Ultra
n=43 Participants
Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
Optive
n=41 Participants
Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
|---|---|---|
|
Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)
|
31.0 units on a scale
Standard Deviation 18.3
|
35.4 units on a scale
Standard Deviation 17.1
|
SECONDARY outcome
Timeframe: Day 35Population: This analysis group includes all subjects with data at visit.
The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.
Outcome measures
| Measure |
Systane Ultra
n=43 Participants
Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
Optive
n=41 Participants
Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
|---|---|---|
|
Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)
|
62.2 units on a scale
Standard Deviation 27.3
|
55.7 units on a scale
Standard Deviation 29.4
|
SECONDARY outcome
Timeframe: Day 35Population: This analysis group includes all subjects with data at visit.
The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.
Outcome measures
| Measure |
Systane Ultra
n=43 Participants
Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
Optive
n=41 Participants
Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
|
|---|---|---|
|
Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)
|
69.5 units on a scale
Standard Deviation 15.8
|
67.1 units on a scale
Standard Deviation 23.6
|
Adverse Events
Pre-treatment
Systane Ultra
Optive
Serious adverse events
| Measure |
Pre-treatment
n=105 participants at risk
All subjects who consented to participate in the study prior to exposure to investigational product
|
Systane Ultra
n=46 participants at risk
All subjects who were exposed to Systane Ultra or run-in therapy
|
Optive
n=47 participants at risk
All subjects who were exposed to Optive or run-in therapy
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/105 • Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). AEs are reported as pre-treatment and treatment-emergent. One subject was randomized to Optive, but was never exposed to product.
An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the product. AEs were obtained as solicited and spontaneous comments from the study subjects, and as observations by the Investigator, as outlined in the protocol.
|
2.2%
1/46 • Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). AEs are reported as pre-treatment and treatment-emergent. One subject was randomized to Optive, but was never exposed to product.
An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the product. AEs were obtained as solicited and spontaneous comments from the study subjects, and as observations by the Investigator, as outlined in the protocol.
|
0.00%
0/47 • Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). AEs are reported as pre-treatment and treatment-emergent. One subject was randomized to Optive, but was never exposed to product.
An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the product. AEs were obtained as solicited and spontaneous comments from the study subjects, and as observations by the Investigator, as outlined in the protocol.
|
|
Gastrointestinal disorders
Gastritis
|
0.95%
1/105 • Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). AEs are reported as pre-treatment and treatment-emergent. One subject was randomized to Optive, but was never exposed to product.
An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the product. AEs were obtained as solicited and spontaneous comments from the study subjects, and as observations by the Investigator, as outlined in the protocol.
|
0.00%
0/46 • Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). AEs are reported as pre-treatment and treatment-emergent. One subject was randomized to Optive, but was never exposed to product.
An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the product. AEs were obtained as solicited and spontaneous comments from the study subjects, and as observations by the Investigator, as outlined in the protocol.
|
0.00%
0/47 • Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). AEs are reported as pre-treatment and treatment-emergent. One subject was randomized to Optive, but was never exposed to product.
An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the product. AEs were obtained as solicited and spontaneous comments from the study subjects, and as observations by the Investigator, as outlined in the protocol.
|
Other adverse events
| Measure |
Pre-treatment
n=105 participants at risk
All subjects who consented to participate in the study prior to exposure to investigational product
|
Systane Ultra
n=46 participants at risk
All subjects who were exposed to Systane Ultra or run-in therapy
|
Optive
n=47 participants at risk
All subjects who were exposed to Optive or run-in therapy
|
|---|---|---|---|
|
Eye disorders
Eye irritation
|
0.95%
1/105 • Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). AEs are reported as pre-treatment and treatment-emergent. One subject was randomized to Optive, but was never exposed to product.
An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the product. AEs were obtained as solicited and spontaneous comments from the study subjects, and as observations by the Investigator, as outlined in the protocol.
|
4.3%
2/46 • Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). AEs are reported as pre-treatment and treatment-emergent. One subject was randomized to Optive, but was never exposed to product.
An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the product. AEs were obtained as solicited and spontaneous comments from the study subjects, and as observations by the Investigator, as outlined in the protocol.
|
6.4%
3/47 • Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). AEs are reported as pre-treatment and treatment-emergent. One subject was randomized to Optive, but was never exposed to product.
An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the product. AEs were obtained as solicited and spontaneous comments from the study subjects, and as observations by the Investigator, as outlined in the protocol.
|
Additional Information
Global Brand Med Affairs Lead, Pharma, GCRA
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