Trial Outcomes & Findings for Evaluation of SYSTANE Ultra Lubricant Eye Drops (NCT NCT00702377)
NCT ID: NCT00702377
Last Updated: 2012-02-02
Results Overview
Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.
COMPLETED
NA
109 participants
Day 0, Day 7, Day 14, Day 28, and Day 42
2012-02-02
Participant Flow
109 dry eye subjects
Randomized, double-masked, parallel design
Participant milestones
| Measure |
SYSTANE Ultra
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
|
OPTIVE Lubricant Eye Drops
OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
56
|
|
Overall Study
COMPLETED
|
52
|
53
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of SYSTANE Ultra Lubricant Eye Drops
Baseline characteristics by cohort
| Measure |
SYSTANE Ultra
n=53 Participants
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
|
OPTIVE Lubricant Eye Drops
n=56 Participants
OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
|
Total
n=109 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
|
34 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0, Day 7, Day 14, Day 28, and Day 42Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.
Outcome measures
| Measure |
SYSTANE Ultra
n=53 Participants
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
|
OPTIVE Lubricant Eye Drops
n=56 Participants
OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
|
|---|---|---|
|
Tear Break-up Time
Day 0
|
4.2 seconds
Standard Deviation 1.9
|
4.5 seconds
Standard Deviation 2.3
|
|
Tear Break-up Time
Day 7
|
4.7 seconds
Standard Deviation 2.8
|
4.2 seconds
Standard Deviation 1.8
|
|
Tear Break-up Time
Day 14
|
4.8 seconds
Standard Deviation 2.8
|
4.2 seconds
Standard Deviation 1.8
|
|
Tear Break-up Time
Day 28
|
4.6 seconds
Standard Deviation 2.6
|
5.2 seconds
Standard Deviation 3.2
|
|
Tear Break-up Time
Day 42
|
4.5 seconds
Standard Deviation 2.3
|
4.2 seconds
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Day 0, Day 7, Day 14, Day 28, Day 42Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.
Outcome measures
| Measure |
SYSTANE Ultra
n=53 Participants
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
|
OPTIVE Lubricant Eye Drops
n=56 Participants
OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
|
|---|---|---|
|
Conjunctival Staining
Day 0
|
2.3 Units on a scale
Standard Deviation 1.1
|
2.8 Units on a scale
Standard Deviation 1.4
|
|
Conjunctival Staining
Day 7
|
2.1 Units on a scale
Standard Deviation 1.1
|
2.5 Units on a scale
Standard Deviation 1.3
|
|
Conjunctival Staining
Day 14
|
2.0 Units on a scale
Standard Deviation 1.2
|
2.2 Units on a scale
Standard Deviation 1.4
|
|
Conjunctival Staining
Day 28
|
1.9 Units on a scale
Standard Deviation 1.1
|
2.4 Units on a scale
Standard Deviation 1.5
|
|
Conjunctival Staining
Day 42
|
1.9 Units on a scale
Standard Deviation 1.0
|
2.7 Units on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Day 0, Day 7, Day 14, Day 28, Day 42Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.
Outcome measures
| Measure |
SYSTANE Ultra
n=53 Participants
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
|
OPTIVE Lubricant Eye Drops
n=56 Participants
OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
|
|---|---|---|
|
Corneal Staining
Day 0
|
4.8 Units on a scale
Standard Deviation 1.8
|
5.3 Units on a scale
Standard Deviation 2.5
|
|
Corneal Staining
Day 7
|
3.6 Units on a scale
Standard Deviation 2.2
|
4.3 Units on a scale
Standard Deviation 3.0
|
|
Corneal Staining
Day 14
|
2.9 Units on a scale
Standard Deviation 2.1
|
4.5 Units on a scale
Standard Deviation 2.9
|
|
Corneal Staining
Day 28
|
3.1 Units on a scale
Standard Deviation 2.1
|
3.8 Units on a scale
Standard Deviation 2.6
|
|
Corneal Staining
Day 42
|
2.9 Units on a scale
Standard Deviation 1.8
|
4.2 Units on a scale
Standard Deviation 2.8
|
Adverse Events
SYSTANE Ultra
OPTIVE Lubricant Eye Drops
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SYSTANE Ultra
n=53 participants at risk
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
|
OPTIVE Lubricant Eye Drops
n=56 participants at risk
OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
5.7%
3/53 • Number of events 3 • From Day 0 to Day 42.
Adverse events were both volunteered and solicited.
|
0.00%
0/56 • From Day 0 to Day 42.
Adverse events were both volunteered and solicited.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI should hold confidential, and not disclose directly or indirectly to any third party other than Contractors, the data arising out of the study. Alcon 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