Trial Outcomes & Findings for Subjective and Objective Performance of Systane Complete Multi-Dose PF Versus Walgreen's Lubricant Balance (NCT NCT06219577)

Results Overview

The Symptom Assessment iN Dry Eye (SANDE) questionnaire. Subjects are asked to place an 'X' on the line to indicate both the frequency and severity of their dry eye symptoms. Each question is scored from 0 to 100. The scores for frequency and severity are used to calculate a total score, where Total Score = square.root\[Q1 \* Q2\]. Higher total score on the questionnaire indicates more frequent or severe dry eye symptoms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

70 participants

Primary outcome timeframe

Change from baseline to 2 weeks

Results posted on

2025-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Systane Complete Multi-Dose PF Systane Complete Multi-Dose PF: Eyedrop	Walgreen's Lubricant Balance Walgreen's Lubricant Balance: Eyedrop
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Systane Complete Multi-Dose PF n=35 Participants Systane Complete Multi-Dose PF: Eyedrop	Walgreen's Lubricant Balance n=35 Participants Walgreen's Lubricant Balance: Eyedrop	Total n=70 Participants Total of all reporting groups
Age, Continuous	41.8 years STANDARD_DEVIATION 14.2 • n=35 Participants	39.4 years STANDARD_DEVIATION 15.1 • n=35 Participants	40.8 years STANDARD_DEVIATION 14.5 • n=70 Participants
Sex: Female, Male Female	25 Participants n=35 Participants	18 Participants n=35 Participants	43 Participants n=70 Participants
Sex: Female, Male Male	10 Participants n=35 Participants	17 Participants n=35 Participants	27 Participants n=70 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Change from baseline to 2 weeks

The Symptom Assessment iN Dry Eye (SANDE) questionnaire. Subjects are asked to place an 'X' on the line to indicate both the frequency and severity of their dry eye symptoms. Each question is scored from 0 to 100. The scores for frequency and severity are used to calculate a total score, where Total Score = square.root\[Q1 \* Q2\]. Higher total score on the questionnaire indicates more frequent or severe dry eye symptoms.

Outcome measures

Outcome measures
Measure	Systane Complete Multi-Dose PF n=35 Participants Systane Complete Multi-Dose PF: Eyedrop	Walgreen's Lubricant Balance n=35 Participants Walgreen's Lubricant Balance: Eyedrop
SANDE Questionnaire	-7.2 score Standard Deviation 11.7	-2.2 score Standard Deviation 6.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 2 weeks

Baseline corneal and conjunctival staining with sodium fluorescein and Wratten filter assessed OU using the Academy of Ophthalmology 5 quadrant scheme. Each quadrant will be graded (0-3) giving a total score (by summation) of 0-15 per eye. A higher score is a worse outcome.

Outcome measures

Outcome measures
Measure	Systane Complete Multi-Dose PF n=35 eyes Systane Complete Multi-Dose PF: Eyedrop	Walgreen's Lubricant Balance n=35 eyes Walgreen's Lubricant Balance: Eyedrop
Corneal and Conjunctival Staining	-2.8 score Standard Deviation 1.8	-0.9 score Standard Deviation 1.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline to 2 weeks

Outcome measures

Outcome measures
Measure	Systane Complete Multi-Dose PF n=35 eyes Systane Complete Multi-Dose PF: Eyedrop	Walgreen's Lubricant Balance n=35 eyes Walgreen's Lubricant Balance: Eyedrop
Non-invasive Tear Breakup Time	3.1 seconds Standard Deviation 2.9	2.2 seconds Standard Deviation 4.5

Adverse Events

Systane Complete Multi-Dose PF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Walgreen's Lubricant Balance

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 Jay Mashouf

Scripps Optometric Group

Phone: 18585302800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place