Trial Review

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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
ACTRN12619000274178
Ethics application status
Approved
Date submitted
13/02/2019
Date registered
25/02/2019
Date last updated
27/10/2021
Date data sharing statement initially provided
25/02/2019
Date results information initially provided
27/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Systane Complete and Systane Hydration on comfort, vision and satisfaction with mini-scleral contact lens wear
Scientific title
The effect of Systane Complete and Systane Hydration on subjective comfort, vision and satisfaction with mini-scleral contact lens wear in experienced contact lens wearers
Secondary ID [1] 297387 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contact lens comfort 311542 0
Condition category
Condition code
Eye 310181 310181 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The order of assignment to the test and control eye drops will be randomized, with a one week washout in between each study arm.
Arm 1: Systane Complete (HP-Guar and mineral oil) lubricant eye drop (test #1) - one drop (approx 40uL) will be instilled once only into the mini-scleral contact lens prior to lens insertion
Arm 2: Systane Hydration (HP Guar and sodium hyaluronate acid) lubricant eye drop (test #2) - one drop (approx 40uL) will be instilled once only into the mini-scleral contact lens prior to lens insertion
Arm 3: Unit dose saline (control) - approx 100uL will be instilled once only to fill the mini-scleral contact lens prior to lens insertion
All of the study eye drops will be administered in-office by the unmasked study investigator.
Intervention code [1] 313645 0
Treatment: Drugs
Comparator / control treatment
Saline (0.9% sodium chloride) - instilled once into mini-scleral contact lens prior to lens insertion
Control group
Active

Outcomes
Primary outcome [1] 319065 0
Subjective comfort ratings will be collected using 0 to 100 visual analogue scales. The questionnaires will be administered on paper forms at the 1 hour and 6 hour post-lens insertion visits, and will be collected via text or online survey at 2 hours and 4 hours post-lens insertion.
Timepoint [1] 319065 0
Assessments will be conducted at 1 hour, 2 hours, 4 hours and 6 hours post-lens insertion. The primary timepoint is unknown and subject to investigation. However, appropriate statistical adjustments will be applied during the analysis to account for multiple comparisons.
Secondary outcome [1] 366899 0
Subjective vision ratings will be collected using 0 to 100 visual analogue scales. The questionnaires will be administered on paper forms at the 1 hour and 6 hour post-lens insertion visits, and will be collected via text or online survey at 2 hours and 4 hours post-lens insertion.
Timepoint [1] 366899 0
Assessments will be conducted at 1 hour, 2 hours, 4 hours and 6 hours post-lens insertion.
Secondary outcome [2] 367260 0
Subjective satisfaction ratings will be collected using 0 to 100 visual analogue scales. The questionnaires will be administered on paper forms at the 1 hour and 6 hour post-lens insertion visits, and will be collected via text or online survey at 2 hours and 4 hours post-lens insertion.
Timepoint [2] 367260 0
Assessments will be conducted at 1 hour, 2 hours, 4 hours and 6 hours post-lens insertion.

Eligibility
Key inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
Healthy experienced contact lens wearers aged 18 to 45 years of age (inclusive);
Willing to refrain from using any eye drops and/or contact lenses 24 hours prior to each study visit;
Spherical Refractive error between +6.00 and -8.00D (inclusive) with cylinder power less than or equal to 0.75D;
Can attain good vision: Best corrected visual acuity of 6/9.5 or better in each eye;
Willing to be fitted with and wear mini-scleral contact lenses for the duration of the study visits;
Willing to attend the scheduled study visits and adhere to instructions.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are currently using topical ocular medication or have used topical ocular medication within 2 weeks of the first visit. Patients who are being treated bilaterally with a marketed artificial tear for dry eye can be considered, provided they discontinue use for 24 hours prior to each visit;
Any contraindications to safe contact lens wear;
Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus;
History of eye surgery within 6 months prior to enrolment in the study;
Any known allergy to the ingredients in Systane Complete, Systane Hydration, saline and/or the lens disinfecting/conditioning solution.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2019
Actual
10/04/2019
Date of last participant enrolment
Anticipated
1/10/2019
Actual
16/10/2019
Date of last data collection
Anticipated
29/11/2019
Actual
15/11/2019
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 25635 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 301959 0
Commercial sector/Industry
Name [1] 301959 0
Alcon Laboratories
Country [1] 301959 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Rupert Myers Building, Barker St.
Kensington NSW 2033
Country
Australia
Secondary sponsor category [1] 301718 0
None
Name [1] 301718 0
Address [1] 301718 0
Country [1] 301718 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302638 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 302638 0
Rupert Myers Building, South wing
Gate 14, Barker St.
Sydney NSW 2052
Ethics committee country [1] 302638 0
Australia
Date submitted for ethics approval [1] 302638 0
14/02/2019
Approval date [1] 302638 0
29/03/2019
Ethics approval number [1] 302638 0
HC190107

Summary
Brief summary
The purpose of this study is to compare subjective comfort, vision and satisfaction ratings, after insertion of mini-scleral (small diameter rigid gas permeable) contact lenses, when a drop of either ocular (eye) lubricant (i) Systane Complete containing HP-Guar and mineral oil (test eye drop #1) or (ii) Systane Hydration containing HP-Guar and sodium hyaluronate (test eye drop #2) is instilled prior to filling with unpreserved saline before inserting the lenses on eye, compared to filling with unpreserved saline alone (control eye drop), up to 6 hours after lens insertion. The hypothesis is that subjective ratings will be superior at any timepoint (2, 4 or 6 hours) post-lens insertion, when a drop of Systane Complete (test eye drop #1) and/or Systane Hydration (test eye drop #2) is instilled in mini-scleral contact lenses prior to filling with unpreserved saline, compared to filling with unpreserved saline (control) alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90902 0
Dr Jacqueline Tan-Showyin
Address 90902 0
Level 3 North Wing Rupert Myers Building,
Gate 14 Barker Street, UNSW Sydney NSW 2052
Country 90902 0
Australia
Phone 90902 0
+61 2 9385 6551
Fax 90902 0
Email 90902 0
jacqueline.tan@unsw.edu.au
Contact person for public queries
Name 90903 0
Dr Jacqueline Tan-Showyin
Address 90903 0
Level 3 North Wing Rupert Myers Building,
Gate 14 Barker Street, UNSW Sydney NSW 2052
Country 90903 0
Australia
Phone 90903 0
+61 2 9385 6551
Fax 90903 0
Email 90903 0
jacqueline.tan@unsw.edu.au
Contact person for scientific queries
Name 90904 0
Prof Fiona Stapleton
Address 90904 0
Level 3 North Wing Rupert Myers Building,
Gate 14 Barker Street, UNSW Sydney NSW 2052
Country 90904 0
Australia
Phone 90904 0
+61 2 9385 4375
Fax 90904 0
Email 90904 0
f.stapleton@unsw.edu.au

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes In press

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSubjective Responses to Various Filling Solutions in the Posterior Fluid Reservoir of Miniscleral Lenses at Application.2022https://dx.doi.org/10.1097/ICL.0000000000000855
N.B. These documents automatically identified may not have been verified by the study sponsor.