Trial Outcomes & Findings for Systane® Ultra Preservative Free Lubricant Eye Drops (NCT NCT05902364)

Last Updated: 2025-08-27

Results Overview

The Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) module is a 20-item, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each item, 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 score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25 and ranged from 0 (minimum) to 100 (maximum). Baseline was defined as the last non-missing value prior to the start date of the study treatment. For subjects who were not exposed, Baseline was defined as the value from Visit 1 (Screening). Higher scores indicate greater symptom bother. No statistical hypothesis was pre-specified for this endpoint. This endpoint was pre-specified for Group 1

Recruitment status

COMPLETED

Study phase

Target enrollment

69 participants

Primary outcome timeframe

Baseline (Day 1), Day 30

Results posted on

2025-08-27

Participant Flow

Of the 69 subjects enrolled in the study (signed an informed consent), 1 subject was determined to be ineligible and was exited from the study prior to treatment. This reporting group includes all eligible subjects.

Participant milestones

Participant milestones
Measure	Group 1 - Dry Eye Symptoms 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days	Group 2 - CL-Related Dryness Discomfort 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days
Overall Study STARTED	34	34
Overall Study COMPLETED	33	34
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 - Dry Eye Symptoms 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days	Group 2 - CL-Related Dryness Discomfort 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days
Overall Study Adverse Event	1	0

Baseline Characteristics

Systane® Ultra Preservative Free Lubricant Eye Drops

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 - Dry Eye Symptoms n=34 Participants 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days	Group 2 - CL-Related Dryness Discomfort n=34 Participants 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days	Total n=68 Participants Total of all reporting groups
Age, Continuous	41.9 years STANDARD_DEVIATION 17.15 • n=93 Participants	35.2 years STANDARD_DEVIATION 11.05 • n=4 Participants	38.6 years STANDARD_DEVIATION 14.71 • n=27 Participants
Sex: Female, Male Female	28 Participants n=93 Participants	29 Participants n=4 Participants	57 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Asian	10 Participants n=93 Participants	16 Participants n=4 Participants	26 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized White	14 Participants n=93 Participants	8 Participants n=4 Participants	22 Participants n=27 Participants
Race/Ethnicity, Customized Multi-racial	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race/Ethnicity, Customized Unknown	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Region of Enrollment Canada	24 participants n=93 Participants	15 participants n=4 Participants	39 participants n=27 Participants
Region of Enrollment New Zealand	10 participants n=93 Participants	19 participants n=4 Participants	29 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1), Day 30

Population: Full Analysis Set with data at visit

Outcome measures

Outcome measures
Measure	Group 1 - Dry Eye Symptoms n=33 Participants 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days
Mean Overall IDEEL SB Score - Group 1 Day 1	45.53 score on a scale Standard Deviation 11.784
Mean Overall IDEEL SB Score - Group 1 Day 30	31.23 score on a scale Standard Deviation 10.854

PRIMARY outcome

Timeframe: Baseline (Day 1), Day 30

Population: Full Analysis Set

The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) is an 8-item, patient-reported outcome questionnaire that evaluates the severity of dry eye symptoms in soft contact lens wearers within the past 2 weeks. For each item, the subject selected a single response for both eyes using a 0-4, 0-5, or 1-6 Likert scale. The overall score was calculated as the sum of the numerical responses for each of the 8 items and ranged from 1 (minimum) to 37 (maximum). A lower CLDEQ-8 score indicates less frequent or less intense symptoms. Baseline was defined as the last non-missing value prior to the start date of the study treatment. For subjects who were not exposed, Baseline was defined as the value from Visit 1 (Screening). No statistical hypothesis is pre-specified for this endpoint. This endpoint was prespecified for Group 2 only.

Outcome measures

Outcome measures
Measure	Group 1 - Dry Eye Symptoms n=34 Participants 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days
Mean Overall CLDEQ-8 Score - Group 2 Day 1	19.4 score on a scale Standard Deviation 5.84
Mean Overall CLDEQ-8 Score - Group 2 Day 30	10.3 score on a scale Standard Deviation 4.64

Adverse Events

Group 1 - Ocular Adverse Events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 1 - Nonocular Adverse Events

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 2 - Ocular Adverse Events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 - Nonocular Adverse Events

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group 1 - Ocular Adverse Events n=68 participants at risk 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days	Group 1 - Nonocular Adverse Events n=34 participants at risk 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days	Group 2 - Ocular Adverse Events n=68 participants at risk 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days	Group 2 - Nonocular Adverse Events n=34 participants at risk 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days
Infections and infestations Naspoharyngitis	— 0/0 • Adverse events (AEs) were collected from time of consent until study exit, approximately one month. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses, as treated. All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.	5.9% 2/34 • Adverse events (AEs) were collected from time of consent until study exit, approximately one month. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses, as treated. All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.	— 0/0 • Adverse events (AEs) were collected from time of consent until study exit, approximately one month. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses, as treated. All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.	2.9% 1/34 • Adverse events (AEs) were collected from time of consent until study exit, approximately one month. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses, as treated. All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.

Additional Information

Clinical Project Lead, Dry Eye

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