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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05902364
Registration number
NCT05902364
Ethics application status
Date submitted
2/06/2023
Date registered
15/06/2023
Date last updated
27/08/2025
Titles & IDs
Public title
Systane® Ultra Preservative Free Lubricant Eye Drops
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Scientific title
Systane® Ultra Preservative Free Lubricant Eye Drops
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Secondary ID [1]
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DEU894-I001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dry Eye
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Systane Ultra PF lubricant eye drops
Experimental: 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
Experimental: 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
Other interventions: Systane Ultra PF lubricant eye drops
Commercially available preservative free eye drops
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Overall IDEEL SB Score - Group 1
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Assessment method [1]
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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
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Timepoint [1]
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Baseline (Day 1), Day 30
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Primary outcome [2]
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Mean Overall CLDEQ-8 Score - Group 2
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline (Day 1), Day 30
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Eligibility
Key inclusion criteria
* 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.
* Other protocol-defined inclusion criteria may apply.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* 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.
* Other protocol-defined exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/10/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/08/2024
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Sample size
Target
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Accrual to date
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Final
69
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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British Columbia
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Country [2]
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Canada
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State/province [2]
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Ontario
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Country [3]
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New Zealand
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State/province [3]
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Auckland
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Country [4]
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New Zealand
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State/province [4]
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Otago
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Alcon Research
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05902364
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Lead, Vision Care
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Address
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Alcon Research, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/64/NCT05902364/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/64/NCT05902364/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05902364
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