ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Contact lens comfort

Condition category

Condition code

Eye

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]

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]

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]

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]

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]

Assessments will be conducted at 1 hour, 2 hours, 4 hours and 6 hours post-lens insertion.

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2052 - Unsw Sydney

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Alcon Laboratories

Address [1]

54 Waterloo Rd.
Macquarie Park NSW 2113

Country [1]

Australia

Primary sponsor type

University

Name

UNSW Sydney

Address

Rupert Myers Building, Barker St.
Kensington NSW 2033

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales Human Research Ethics Committee

Ethics committee address [1]

Rupert Myers Building, South wing
Gate 14, Barker St.
Sydney NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/02/2019

Approval date [1]

29/03/2019

Ethics approval number [1]

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

Dr Jacqueline Tan-Showyin

Address

Level 3 North Wing Rupert Myers Building,
Gate 14 Barker Street, UNSW Sydney NSW 2052

Country

Australia

Phone

+61 2 9385 6551

Fax

jacqueline.tan@unsw.edu.au

Contact person for public queries

Name

Jacqueline Tan-Showyin

Address

Level 3 North Wing Rupert Myers Building,
Gate 14 Barker Street, UNSW Sydney NSW 2052

Country

Australia

Phone

+61 2 9385 6551

Fax

jacqueline.tan@unsw.edu.au

Contact person for scientific queries

Name

Fiona Stapleton

Address

Level 3 North Wing Rupert Myers Building,
Gate 14 Barker Street, UNSW Sydney NSW 2052

Country

Australia

Phone

+61 2 9385 4375

Fax

f.stapleton@unsw.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Subjective Responses to Various Filling Solutions in the Posterior Fluid Reservoir of Miniscleral Lenses at Application.	2022	https://dx.doi.org/10.1097/ICL.0000000000000855

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically