Trial Outcomes & Findings for Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes (NCT NCT00796926)

Results Overview

Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

6 weeks

Results posted on

2011-10-07

Participant Flow

Participant milestones

Participant milestones
Measure	Systane Ultra four times a day for six weeks in each eye	Refresh Four times a day for 6 weeks in each eye
Overall Study STARTED	15	15
Overall Study COMPLETED	14	15
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Systane Ultra n=15 Participants four times a day for six weeks in each eye	Refresh n=15 Participants Four times a day for 6 weeks in each eye	Total n=30 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	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	56.2 years STANDARD_DEVIATION 5.8 • n=5 Participants	55.7 years STANDARD_DEVIATION 5.5 • n=7 Participants	55.9 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Singapore	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: intention to treat

Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum

Outcome measures

Outcome measures
Measure	Systane Ultra n=14 Participants four times a day for six weeks in each eye	Refresh n=15 Participants Four times a day for 6 weeks in each eye
Visual Analog Score (VAS)	21.55 scores on a scale Standard Deviation 16.8	27.27 scores on a scale Standard Deviation 15.0

SECONDARY outcome

Timeframe: 6 weeks

This is graded in the 5 zones of each cornea according to number of spots of corneal fluorescein staining, confluency of spots and presence of filaments if any

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

This is measured by the TearLab (Ocusense) system

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

This is determined by anterior segment OCT visante system

Outcome measures

Outcome data not reported

Adverse Events

Systane Ultra

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Refresh

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Louis Tong

Singapore National Eye Center

Phone: 65 62277255

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place