Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001036303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
17/08/2026
Date registered
Help: Date registered
24/08/2026
Date last updated
Help: Date last updated
24/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
24/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of dry eye symptom relief with SYSTANE® PRO and Artelac® Complete lubricating eye drops
Scientific title
Prospective, randomised, controlled, double-masked, non-inferiority crossover trial comparing change in dry eye symptom score after 1 month use each of SYSTANE® PRO and Artelac® Complete preservative-free lubricating eye drops in adult participants with dry eye disease
Additional trial identifiers [1] 318206 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Dry eye disease 343262 0
Condition category
Condition code
Eye 339379 339379 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants self-apply SYSTANE® PRO preservative-free eye drops at a location of their choice, 1-2 drops, 2 times a day for 4 weeks. Ocular surface symptoms and signs are collected at baseline and after 4 weeks.
After 4 weeks participants crossover to self-apply Artelac® Complete preservative-free eye drops, 1-2 drops, 4 times a day, at a location of their choice, for a further 4 weeks after which time ocular surface symptoms and signs are again collected. There is no washout period in between.

Participant diaries are used throughout to record compliance, and for each product, bottles are collected after 4 weeks' use and weights compared, pre and post-study, as a further measure of compliance.
Intervention code [1] 335106 0
Treatment: Other
Description of the comparator or control
Participants apply Artelac® Complete preservative-free eye drops, 1-2 drops, 4 times a day for 4 weeks. Ocular surface symptoms and signs are collected at baseline and after 4 weeks.
After 4 weeks participants crossover to apply SYSTANE® PRO preservative-free eye drops, 1-2 drops, 2 times a day for a further 4 weeks after which time ocular surface symptoms and signs are again collected. There is no washout period in between.

Participant diaries are used, throughout, to record compliance, and for each product, bottles are collected after 4 weeks' use and weights compared, pre and post-study, as a further measure of compliance.
Control group
Active

Outcomes
Primary outcome [1] 346579 0
Ocular surface symptom score
Timepoint [1] 346579 0
Baseline and after 4 weeks of daily application of each eye drop (i.e. at baseline, at 4 weeks (after drop 1) and at 8 weeks (after drop 2), 2 times daily for SYSTANE® PRO and 4 times daily for Artelac® Complete.
Secondary outcome [1] 466457 0
User satisfaction with eye drops
Timepoint [1] 466457 0
Baseline and after 4 weeks of daily application of each eye drop (i.e. at baseline, at 4 weeks (after drop 1) and at 8 weeks (after drop 2).
Secondary outcome [2] 466459 0
User preference between products
Timepoint [2] 466459 0
At 8 weeks after baseline (following two consecutive 4 week periods of applying each of the two eye drop products, 2 times daily for SYSTANE® PRO and 4 times daily for Artelac® Complete)
Secondary outcome [3] 466460 0
Non-invasive breakup time
Timepoint [3] 466460 0
At baseline and after 4 weeks of daily application of each eye drop (i.e. at baseline, at 4 weeks (after drop 1) and at 8 weeks (after drop 2, 2 times daily for SYSTANE® PRO and 4 times daily for Artelac® Complete).
Secondary outcome [4] 466461 0
Lipid layer grade (LLG)
Timepoint [4] 466461 0
Baseline and after 4 weeks of daily application of each eye drop (i.e. at baseline, at 4 weeks (after drop 1) and at 8 weeks (after drop 2), 2 times daily for SYSTANE® PRO and 4 times daily for Artelac® Complete.
Secondary outcome [5] 466462 0
Lipid layer thickness (LLT)
Timepoint [5] 466462 0
At baseline and after 4 weeks of daily application of each eye drop (i.e. at baseline, at 4 weeks (after drop 1) and at 8 weeks (after drop 2), 2 times daily for SYSTANE® PRO and 4 times daily for Artelac® Complete.
Secondary outcome [6] 466463 0
Tear evaporation rate
Timepoint [6] 466463 0
Baseline and 4 weeks after daily application of each eye drop (i.e. at baseline, at 4 weeks (after drop 1) and at 8 weeks (after drop 2), 2 times daily for SYSTANE® PRO and 4 times daily for Artelac® Complete.
Secondary outcome [7] 466464 0
Bulbar conjunctival hyperaemia
Timepoint [7] 466464 0
Baseline and 4 weeks after daily application of each eye drop (i.e. at baseline, at 4 weeks (after drop 1) and at 8 weeks (after drop 2), 2 times daily for SYSTANE® PRO and 4 times daily for Artelac® Complete.
Secondary outcome [8] 466465 0
Blink rate
Timepoint [8] 466465 0
Baseline and 4 weeks after daily application of each eye drop (i.e. at baseline, at 4 weeks (after drop 1) and at 8 weeks (after drop 2), 2 times daily for SYSTANE® PRO and 4 times daily for Artelac® Complete.
Secondary outcome [9] 466466 0
Blink completeness
Timepoint [9] 466466 0
Baseline and 4 weeks after daily application of each eye drop (i.e. at baseline, at 4 weeks (after drop 1) and at 8 weeks (after drop 2).
Secondary outcome [10] 466467 0
Duration of symptom relief after drop application
Timepoint [10] 466467 0
Baseline and after 4 weeks of daily application of each eye drop (i.e. at baseline, at 4 weeks (after drop 1) and at 8 weeks (after drop 2), 2 times daily for SYSTANE® PRO and 4 times daily for Artelac® Complete.

Eligibility
Key inclusion criteria
• Age equal to or greater than 18 years
• Minimum of 6 months history of self-reported dry eye
• Dry eye diagnosis according to the Tear Film and Ocular Surface Society Dry Eye Workshop III (TFOS DEWS III) diagnostic criteria (6-item Ocular Surface Disease Index (OSDI-6) score of greater or equal to 4 plus any one or more of the following signs: Non-invasive tear breakup time (NIBUT) less than 10 seconds, hyperomsomolarity of greater than or equal to 308mOsm/L or an interocular difference in osmolarity of greater than 8 mOsm/L; corneal fluorescein staining of more than 5 corneal spots, conjunctival lissamine green staining of more than 9 conjunctival spots, or lid wiper epitheliopathy of greater than or equal to 2mm in length and greater than or equal to 25% sagittal width).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Non-normal lid architecture affecting lid closure/blink
• Anaesthetic cornea
• Active ocular allergies or history of frequent ocular allergies
• Severe dry eye disease not manageable with only topical lubricating drops
• Unwillingness to restrict topical eye drop use to only the study tear supplement
• Patients who are using other ophthalmological drops of any kind
• Contact lens wear within 1 week of study commencement or during the study
• Warm compress therapy, unless stable for at least 3 months prior to study enrolment and maintained at the same frequency throughout the trial
• History of in-office therapies for dry eye disease (DED) such as thermal pulsation or light therapy in the last 12 months
• History of ocular surgery (such as refractive or cataract surgery) in either eye within 6 months of the screening visit
• Reduced visual acuity (less than or equal to 20/200), significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection or inflammation unrelated to dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration
• A systemic condition or disease considered unstable or judged by the investigator to be incompatible with participation in the study (including but not limited to current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease), pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment allocation occurs consecutively according to a predetermined randomisation schedule with treatment allocation concealed to all parties throughout. Participants are provided with the product in an opaque envelope after the baseline visit to avoid risk of investigator influence in treatment allocation. This envelope, marked only with participant code, is prepared by a third party otherwise uninvolved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation via random.org by a third party uninvolved in the data collection.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size justification: Power calculations were conducted using PASS version 24.0.5 (NCSS Statistical Software LLC, Utah, USA), with the OSDI score as the outcome measure for determining sample size, and a non-inferiority margin of less than or equal to 7.3. The SD of OSDI scores was estimated to be 15. The results show that a minimum of 73 participants was required to a clinically meaningful difference, with 90% power (ß = 0.2), at a one-sided statistical significance level of 5% (a = 0.05). Accounting for a 10% dropout rate, a total of 82 participants would need to be recruited.
Statistical analysis: The significance of overall treatment will be assessed using repeated measures two-way analysis of variance (ANOVA) for continuous variables. Normality of distributions will be confirmed by Kolmogorov-Smirnov testing (p greater than 0.05). Non-normally distributed continuous data (NIBUT) will be logarithmically transformed, and ordinal data (LLG) converted to rank-values before analysis. Categorical data (treatment preference) will be compared using Fisher's exact test. All tests will be two-tailed, with p less than 0.05 being considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/09/2026
Actual
Date of last participant enrolment
Anticipated
17/08/2027
Actual
Date of last data collection
Anticipated
31/10/2027
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment outside Australia
Country [1] 28446 0
New Zealand
State/province [1] 28446 0
Auckland

Funding & Sponsors
Funding source category [1] 322769 0
Commercial sector/Industry
Name [1] 322769 0
Alcon
Country [1] 322769 0
Australia
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 325691 0
None
Name [1] 325691 0
Address [1] 325691 0
Country [1] 325691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321208 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 321208 0
Ethics committee country [1] 321208 0
New Zealand
Date submitted for ethics approval [1] 321208 0
18/07/2026
Approval date [1] 321208 0
28/07/2026
Ethics approval number [1] 321208 0
2026 EXP 26391

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 153018 0
Prof Jennifer P Craig
Address 153018 0
The University of Auckland, Private Bag 92019, Auckland 1142
Country 153018 0
New Zealand
Phone 153018 0
+64 9 923 8173
Fax 153018 0
Email 153018 0
[email protected]
Contact person for public queries
Name 153019 0
Jennifer Craig
Address 153019 0
The University of Auckland, Private Bag 92019, Auckland 1142
Country 153019 0
New Zealand
Phone 153019 0
+64 9 923 8173
Fax 153019 0
Email 153019 0
[email protected]
Contact person for scientific queries
Name 153020 0
Jennifer Craig
Address 153020 0
The University of Auckland, Private Bag 92019, Auckland 1142
Country 153020 0
New Zealand
Phone 153020 0
+64 9 923 8173
Fax 153020 0
Email 153020 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Ethical restrictions according to approved data management plan



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.