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Trial registered on ANZCTR


Registration number
ACTRN12619000361101
Ethics application status
Approved
Date submitted
4/03/2019
Date registered
6/03/2019
Date last updated
21/03/2019
Date data sharing statement initially provided
6/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the prophylactic benefits of artificial tear supplements in an adverse environment
Scientific title
Exploring the prophylactic benefits of Systane® Complete for individuals with dry eye in an adverse environment
Secondary ID [1] 297603 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye disease 311860 0
Condition category
Condition code
Eye 310456 310456 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Instillation of Systane Ultra (SU) and Systane Complete (SC) (Alcon,Inc.) artificial tear supplements before exposure to a high air flow environment.

Participants will be randomized to have 1 drop (20 microlitres) of SU applied topically to either the right or left eye and a drop of SC (20 microlitres) applied to the partner eye. Tear quality will be assessed before and 10 minutes after drop instillation, and then again after exposure 20 minutes after drop instillation to an adverse environment (moving air, at a speed of 3.2 metres per second, generated by a standing fan, placed 1 metre from the eyes, for 2.5 minutes).

In a subsequent visit, at least 24 hours later, the drops are applied to the right and left eyes in the reverse order so that both the supplements are applied to both eyes over the course of the study.

Systane Ultra contains:
Active ingredients: Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%
Inactive ingredients: Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1)0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Systane Complete contains:
Active ingredient: Propylene Glycol 0.6%
Inactive ingredient: boric acid, dimyristoyl phosphatidylglycerol, edatate disodium, hydroxypropyl guar, mineral oil, polyoxl 40 stearate, POLYQUAD® (polyquaternium-1) 0.001% preservative, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Intervention code [1] 313838 0
Prevention
Comparator / control treatment
Crossover - the two tear supplements (SC vs SU as the referent comparator) will be compared to each other and relative to baseline.
Control group
Active

Outcomes
Primary outcome [1] 319326 0
Non-invasive tear film stability (NIKBUT) measured objectively by the Oculus Keratograph 5M
Timepoint [1] 319326 0
Baseline
10 minutes after drop instillation
Within 5 minutes of adverse environment exposure (primary endpoint)
Primary outcome [2] 319344 0
Lipid layer grade evaluated by a masked observer from interferometric video images captured on the Ocular Keratograph 5M
Timepoint [2] 319344 0
Baseline
10 minutes after drop instillation
Within 5 minutes of adverse environment exposure (primary endpoint)
Secondary outcome [1] 367760 0
Symptom severity evaluated on a visual analogue scale
Timepoint [1] 367760 0
Baseline
10 minutes after drop instillation
Within 5 minutes of adverse environment exposure
Secondary outcome [2] 367762 0
Tear Meniscus Height (TMH) quantified using the digital callipers of the Oculus Keratograph 5M
Timepoint [2] 367762 0
Baseline
10 minutes after drop instillation
Within 5 minutes of adverse environment exposure
Secondary outcome [3] 367763 0
Bulbar hyperaemia quantified objectively by the Oculus Keratograph 5M
Timepoint [3] 367763 0
Baseline
10 minutes after drop instillation
Within 5 minutes of adverse environment exposure
Secondary outcome [4] 367769 0
Lid Wiper Epitheliopathy (LWE)
Timepoint [4] 367769 0
At screening
Following adverse environment exposure

Eligibility
Key inclusion criteria
• Normal lid architecture, and closure
• Dry eye diagnosis according to the TFOS DEWS II diagnostic criteria (Symptoms: DEQ-5 or OSDI and Signs: at least 1 positive finding on NIKBUT/osmolarity/staining).

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Non-normal lid architecture affecting lid closure/blink
• Artificial tear supplement use < 48 hours prior to study
• Marked bilateral asymmetry in tear film or ocular surface status
• Wear of contact lenses within 48 hours of study commencement or during the study
• Punctal plugs (unless permanent)
• History of ocular surgery (such as refractive or cataract surgery) in either eye within 3 months of the screening visit
• History or presence of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or patient safety. This includes but is not limited to significantly reduced visual acuity (below 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; ocular herpetic infection.
• Use of topical medications that might interfere with the study outcomes, or deemed to be contraindicated for participation
• 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, history of myocardial infarction)
• Self-reported pregnancy or lactation
• Active or uncontrolled severe systemic allergy, chronic seasonal allergies, rhinitis or sinusitis requiring treatment (with antihistamines, decongestants, oral or aerosol steroids) at the time of screening
• Use of medication known to cause ocular drying (including but not limited to antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, diuretics, phenothiazines, steroids) within 30 days of the screening visit
• Participation in any clinical trial with a new active substance or a new device within 30 days of the screening visit

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Product allocation will be randomised and prospectively double-masked to minimize risk of bias. Products will be over-labelled to obscure contents. A randomisation schedule for the sample will be derived by computer-generated random number allocation, and applied to sequentially enrolled participants. The randomisation schedule will be pre-determined prior to patient recruitment, such that the investigator involved in baseline participant assessment will have no involvement in treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software (i.e. computerised sequence generation) will be used to generate a randomisation schedule. Participants will be assigned treatment according to sequential enrolment.
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
Prospective, randomised, double-masked, contralateral
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The significance of overall treatment, time, and treatment-by-time interaction effects to be assessed using repeated measures two-way analysis of variance (ANOVA) for continuous variables with normal distributions confirmed by Kolmogorov-Smirnov testing (p > 0.05). Non-normally distributed continuous (NIKBUT) and ordinal data (LLG and LWE) will be converted to rank-values prior to undergoing analysis. Multiplicity-adjusted post-hoc assessment of individual treatment and time effects will be conducted using Sidak's test. Categorical data (treatment preference) will be compared using Fisher's exact test. All tests will be two-tailed and p < 0.05 considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21327 0
New Zealand
State/province [1] 21327 0
Auckland

Funding & Sponsors
Funding source category [1] 302148 0
Commercial sector/Industry
Name [1] 302148 0
Alcon Inc
Address [1] 302148 0
Unit 10/25 Frenches Forest Road East,
Frenchs Forest,
NSW 2086
Country [1] 302148 0
Australia
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 301989 0
None
Name [1] 301989 0
Address [1] 301989 0
Country [1] 301989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302830 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 302830 0
Private Bag 92019
Auckland 1142
Ethics committee country [1] 302830 0
New Zealand
Date submitted for ethics approval [1] 302830 0
22/11/2018
Approval date [1] 302830 0
07/12/2018
Ethics approval number [1] 302830 0
022492

Summary
Brief summary
The topical application of eye drops is reported to have protective effects in low relative humidity environments. The single application of a lipomimetic formulation (Systane® Balance) demonstrated superior prophylactic efficacy against exposure to validated adverse environmental conditions induced by high air flow in subjects with mild-to-moderate dry eye compared to the non-lipid formulation, Systane® Ultra (SU). The newest addition to the Systane® family of drops, Systane® Complete (SC), offers the potential for similar or improved protection through increased HP Guar concentrations to confer additional moisture retention and increased surface lubricity from advanced lipid-delivering nanotechnology.

Scientific literature to support the clinical benefits of SC is as yet unavailable. This project offers an opportunity to explore the benefits of SC application prior to exposure to an adverse environment. Knowledge that the tear film can be boosted so that it is better able to withstand adverse environments such as windy conditions or low relative humidity (e.g. air-conditioned environment / air travel) would be useful for clinicians managing patients affected by dry eye disease.


The study aims to explore the ocular surface benefits in improving tear film quality and prophylactic potential of SC in resisting dryness-related clinical signs and symptoms following exposure to an adverse environment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91534 0
A/Prof Jennifer P Craig
Address 91534 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
Country 91534 0
New Zealand
Phone 91534 0
+64 9 373 7599
Fax 91534 0
+62 9 367 7173
Email 91534 0
jp.craig@auckland.ac.nz
Contact person for public queries
Name 91535 0
Dr Alex Muntz
Address 91535 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
Country 91535 0
New Zealand
Phone 91535 0
+64 9 373 7599
Fax 91535 0
Email 91535 0
a.muntz@auckland.ac.nz
Contact person for scientific queries
Name 91536 0
A/Prof Jennifer P Craig
Address 91536 0
Department of Ophthalmology
The University of Auckland
Private Bag 92019
Auckland 1142
Country 91536 0
New Zealand
Phone 91536 0
+64 9 373 7599
Fax 91536 0
Email 91536 0
jp.craig@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results