Trial Outcomes & Findings for Clinical Evaluation of Systane® Gel Drops in Dry Eye Subjects (NCT NCT02380248)
NCT ID: NCT02380248
Last Updated: 2018-07-02
Results Overview
Corneal staining was assessed by the Investigator through slit-lamp examination and reported on a scale of 0-3, where 0=normal (no staining) and 3=severe (numerous coalescent macropunctate areas and/or patches), for the 5 quadrants of each eye. The scores at each visit were summed by eye for each subject. The overall corneal staining score for the subject at each visit was then computed as the average of the sum from both eyes. Thus, the overall scores ranged between 0-15 with higher scores reflecting more damage to the corneal surface.
COMPLETED
NA
207 participants
Baseline (Day 0), Day 45, Day 90
2018-07-02
Participant Flow
Subjects were recruited from 13 study centers in India.
Of the 207 enrolled, 6 subjects were exited as screen failures prior to treatment. In addition, 1 subject met the entry criteria, but discontinued prior to the first instillation of investigational product (IP). This reporting group includes all treated subjects (200).
Participant milestones
| Measure |
Systane
Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID (4 times/day) in each eye for 90 days
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
186
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Systane
Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID (4 times/day) in each eye for 90 days
|
|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
This analysis population includes all enrolled subjects who had a baseline and at least 1 postbaseline assessment of corneal staining (Full Analysis Set). Number analyzed includes number of subjects with non-missing response.
Baseline characteristics by cohort
| Measure |
Systane
n=200 Participants
Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days
|
|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 13.43 • n=200 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=200 Participants
|
|
Corneal Staining
|
5.7 units on a scale
STANDARD_DEVIATION 2.12 • n=190 Participants • This analysis population includes all enrolled subjects who had a baseline and at least 1 postbaseline assessment of corneal staining (Full Analysis Set). Number analyzed includes number of subjects with non-missing response.
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Day 45, Day 90Population: Full Analysis Set. Number analyzed includes number of subjects with non-missing response in specified category.
Corneal staining was assessed by the Investigator through slit-lamp examination and reported on a scale of 0-3, where 0=normal (no staining) and 3=severe (numerous coalescent macropunctate areas and/or patches), for the 5 quadrants of each eye. The scores at each visit were summed by eye for each subject. The overall corneal staining score for the subject at each visit was then computed as the average of the sum from both eyes. Thus, the overall scores ranged between 0-15 with higher scores reflecting more damage to the corneal surface.
Outcome measures
| Measure |
Systane
n=190 Participants
Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days
|
|---|---|
|
Change From Baseline in Corneal Staining at All Study Time Points
Change from baseline at Day 45
|
-2.7 units on a scale
Standard Error 0.14
|
|
Change From Baseline in Corneal Staining at All Study Time Points
Change from baseline at Day 90
|
-4.0 units on a scale
Standard Error 0.16
|
Adverse Events
Pretreatment
Systane
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Scientific Associate Director, GCRA-GDD
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