Systane® Ultra Preservative Free Lubricant Eye Drops

NCT05902364 | Completed Results

• 1 other identifier: DEU894-I001
• Study Type: interventional
• Target: 69
• Locations: 2 countries
• Sites: 4

Brief Summary

The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Ultra Preservative-Free (PF) in subjects experiencing dry eye symptoms (Group 1) and contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2). Statistical analyses will be presented by group. This study will be conducted in Canada, Australia, and New Zealand.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Mean Overall IDEEL SB Score - Group 1

  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

  Baseline (Day 1), Day 30

• Mean Overall CLDEQ-8 Score - Group 2

  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.

  Baseline (Day 1), Day 30

Study Arms (2)

Group 1 - Dry Eye Symptoms

EXPERIMENTAL

1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days

Other: Systane Ultra PF lubricant eye drops

Group 2 - CL-Related Dryness Discomfort

EXPERIMENTAL

1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days

Other: Systane Ultra PF lubricant eye drops

Interventions

Systane Ultra PF lubricant eye drops OTHER

Commercially available preservative free eye drops

Also known as: Systane Ultra Preservative-Free

Group 1 - Dry Eye Symptoms; Group 2 - CL-Related Dryness Discomfort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be able to understand and sign an informed consent form.
• Subject with mild to moderate dry eye.
• Subject with contact lens-related dry eye symptoms.

You may not qualify if:

• Has suffered any ocular injury to either eye in the past 3 months prior to screening.
• Has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (4)

Integra Eye Care

Burnaby, British Columbia, V5E 1G3, Canada

Location

University of Waterloo School of Optometry

Waterloo, Ontario, N2L 3G1, Canada

Location

University of Auckland

Grafton, Auckland, 1142, New Zealand

Location

Rose Optometry

Frankton, Otago, 3204, New Zealand

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Clinical Project Lead, Dry Eye
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 15, 2023
• Study Start: October 28, 2023
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); NZ (2)