Trial Outcomes & Findings for Systane® Complete Preservative Free Lubricant Eye Drops (NCT NCT05932225)

Last Updated: 2025-04-04

Results Overview

The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, the subject selected a single response for both eyes, where 0="None of the time" (Q1) or "I did not have this symptom/Not Applicable" (Q2-20) to 4="All of the time" (Q1) or "Very Much" (Q2-20). The overall Symptom Bother score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25, for an overall resultant score ranging from 0 to 100. Higher scores indicate greater symptom bother. No statistical hypothesis was pre-specified for this endpoint.

Recruitment status

COMPLETED

Study phase

Target enrollment

71 participants

Primary outcome timeframe

Baseline (Day 1 pretreatment), Day 30

Results posted on

2025-04-04

Participant Flow

Subjects were recruited from 4 investigative sites located in Canada.

Of the 71 enrolled, 3 participants did not meet the inclusion criteria and were exited from the study. This reporting group includes all eligible subjects (68).

Participant milestones

Participant milestones
Measure	Aqueous Deficient Dry Eye 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production.	Evaporative Dry Eye 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient oil in their tears (meibomian gland dysfunction).	Mixed Dry Eye 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production and insufficient oil in their tears (meibomian gland dysfunction).
Overall Study STARTED	14	32	22
Overall Study COMPLETED	13	29	22
Overall Study NOT COMPLETED	1	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Aqueous Deficient Dry Eye 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production.	Evaporative Dry Eye 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient oil in their tears (meibomian gland dysfunction).
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	1	0
Overall Study As detailed in the Clinical Study Report	0	2

Baseline Characteristics

Systane® Complete Preservative Free Lubricant Eye Drops

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aqueous Deficient Dry Eye n=14 Participants 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production.	Evaporative Dry Eye n=32 Participants 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient oil in their tears (meibomian gland dysfunction).	Mixed Dry Eye n=22 Participants 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production and insufficient oil in their tears (meibomian gland dysfunction).	Total n=68 Participants Total of all reporting groups
Age, Continuous	49.0 years STANDARD_DEVIATION 17.62 • n=5 Participants	49.2 years STANDARD_DEVIATION 14.34 • n=7 Participants	55.0 years STANDARD_DEVIATION 11.99 • n=5 Participants	51.1 years STANDARD_DEVIATION 14.43 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	24 Participants n=7 Participants	11 Participants n=5 Participants	47 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	21 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 participants n=5 Participants	10 participants n=7 Participants	3 participants n=5 Participants	16 participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	11 participants n=5 Participants	21 participants n=7 Participants	19 participants n=5 Participants	51 participants n=4 Participants
Race/Ethnicity, Customized Unknown	4 participants n=5 Participants	9 participants n=7 Participants	2 participants n=5 Participants	15 participants n=4 Participants
Race/Ethnicity, Customized Unconfirmed	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	11 participants n=7 Participants	10 participants n=5 Participants	22 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Race/Ethnicity, Customized White	8 participants n=5 Participants	9 participants n=7 Participants	9 participants n=5 Participants	26 participants n=4 Participants
Race/Ethnicity, Customized Mixed	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment Canada	14 participants n=5 Participants	32 participants n=7 Participants	22 participants n=5 Participants	68 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1 pretreatment), Day 30

Population: Full Analysis Set: All subjects/eyes exposed to at least one dose of Systane Complete PF with data at visit

Outcome measures

Outcome measures
Measure	Aqueous Deficient Dry Eye n=14 Participants 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production.	Evaporative Dry Eye n=32 Participants 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient oil in their tears (meibomian gland dysfunction).	Mixed Dry Eye n=22 Participants 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production and insufficient oil in their tears (meibomian gland dysfunction).
Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group Day 30	31.26 score on a scale Standard Deviation 9.449	32.16 score on a scale Standard Deviation 11.080	32.91 score on a scale Standard Deviation 10.016
Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group Baseline (Day 1 pretreatment)	41.36 score on a scale Standard Deviation 11.095	47.08 score on a scale Standard Deviation 12.689	47.63 score on a scale Standard Deviation 11.756

PRIMARY outcome

Timeframe: Baseline (Day 1 pretreatment), Day 30

Population: Full Analysis Set: All subjects/eyes exposed to at least one dose of Systane Complete PF with data at visit

Outcome measures

Outcome measures
Measure	Aqueous Deficient Dry Eye n=68 Participants 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production.	Evaporative Dry Eye 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient oil in their tears (meibomian gland dysfunction).	Mixed Dry Eye 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production and insufficient oil in their tears (meibomian gland dysfunction).
Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - All Subjects Baseline (Day 1 pretreatment)	46.08 score on a scale Standard Deviation 12.150	—	—
Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - All Subjects Day 30	32.24 score on a scale Standard Deviation 10.265	—	—

Additional Information

Clinical Trial Lead, CDMA Trial Management Operations

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

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