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Trial registered on ANZCTR

Registration number

ACTRN12613001323718

Ethics application status

Approved

Date submitted

27/11/2013

Date registered

29/11/2013

Date last updated

24/07/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effects of lipid supplementation in contact lens wear comfort

Scientific title

Effect of exogenous phospholipid supplementations among habitual soft contact lens wearers in their ocular comfort

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1150-7806

Trial acronym

Linked study record

Health condition

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

Ocular comfort

Condition category

Condition code

Eye

Normal eye development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

There are two interventions used.

1. A phospholipid emulsion drop (Systane Balance, Alcon)

2. A phospholipid liposomal spray (Tearsagain, Biorevive)

All participants will use both interventions and placebos during the study period which is 4 separate phases (4 x 14 days). The dose used for drop is 0.05 ml thrice daily for 14 days and for spray is 0.05 ml thrice daily for 14 days. The drop is applied directly to the eye with contact lens wear and the spray is sprayed on to the closed eyelid margins with contact lens wear. To monitor adherence a patient check list will be provided for the participants. The washout period between each treatment is a minimum 48 hours.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

There are two placebos used.

1. A saline drop (Saline contains unpreservative sodium chloride in water 0.9%, (weight/volume))

2. A saline spray

All participants will use both interventions and placebos during the study period which is 4 separate phases (4 x 14 days). The dose used for drop is 0.05 ml thrice daily for 14 days and for spray is 0.05 ml thrice daily for 14 days The drop is applied directly to the eye with contact lens wear and the spray is sprayed on to the closed eyelid margins with contact lens wear. To monitor adherence a patient check list will be provided for the participants. The washout period between each placebo is a minimum 48 hours.

Control group

Placebo

Outcomes

Primary outcome [1]

Ocular comfort score of > 32.0 measured using Ocular Comfort Index

Timepoint [1]

At baselines and at day 1 and day 14 after the use of intervention/ placebo

Secondary outcome [1]

Tear evaporation rate of > 55.6 g/m^2h measured using a modified dermatology instrument named VapoMeter

Timepoint [1]

Baseline visits and day 1 and day 14 after the intervention/placebo

Eligibility

Key inclusion criteria

Habitual contact lens wear

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

No history of contact lens wear

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)

Central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomised table created by computer software

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
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

The sample size was calculated to determine a significant difference of 36 g/m^2h between repeat measurements at the 5% level of significance corrected for multiple comparisons and with 80% power. The within subject standard deviation of 34 g/m^2h used in this calculation was based on a pilot study. The expected difference of 36 g/m^2h was based on the observed change with contact lens wear from the pilot study.

A linear mixed model will be used to compare the clinical, functional and biochemical variables of the contact lens wearers during use of intervention or placebo. Associations between different variables will be assessed using Pearson or Spearman correlation coefficient where appropriate.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

12/03/2013

Actual

2/05/2013

Date of last participant enrolment

Anticipated

30/09/2013

Actual

5/09/2013

Date of last data collection

Anticipated

Actual

31/10/2013

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Brien Holden Vision Institute

Address [1]

Level 5 North Wing, Rupert Myers Building
Gate 14 Barker Street, University of New South Wales
Kensington, NSW, 2033

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Brien Holden Vision Institute

Address

Level 5 North Wing, Rupert Myers Building
Gate 14 Barker Street, University of New South Wales
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]

Human Research Ethics Advisory (HREA), University of New South Wales

Ethics committee address [1]

Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales 
SYDNEY NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/11/2012

Approval date [1]

12/12/2012

Ethics approval number [1]

HC12584

Summary

Brief summary

Tear film lipid layer plays an important role in maintaining tear film stability and ocular comfort. Contact lens wear compromises ocular surface equilibrium by disrupting the lipid layer which results in lens related ocular dryness and discomfort. The troublesome symptom of the contact lens wear often leads to discontinuation of lens wear and hence is critical for the researchers to design ways to overcome the challenge. Artificial tear supplements have been used to increase ocular comfort. This study aims to understand tear film lipids of contact lens wearers and also to evaluate the effect of exogenous lipid supplements on different aspects of tear film lipid layer.
Hypotheses:
1. Improved contact lens comfort is associated with a thicker lipid layer and decreased lipid degradation resulting in reduced tear evaporation.
2. Use of an exogenous tear lipid supplement increases lipid thickness, reduces lipid degradation, increases tear stability, reduces tear evaporation and consequently improves contact lens comfort.

Trial website

Trial related presentations / publications

1.	Lipid Supplements and Clinical Aspects of Tear Film in Habitual Lens Wearers. Athira Rohit, Mark Willcox, Fiona Stapleton. Optometry and Vision Science, 2017; 94 (2); 174-182.
2.	Effects of Lipid Supplements on Tear Biochemistry in Contact Lens Wearers. Athira Rohit, Mark Willcox, Fiona Stapleton. Optometry and Vision Science, 2016; 93 (10); 1203-1209.
1.	Lipid supplements & biochemical aspects of tear film in habitual lens wearers. Athira Rohit, Mark Willcox, Fiona Stapleton. Poster presentation at the Association for Research in Vision and Ophthalmology (ARVO), Seattle, US, May 2016.
2.	Effect of a lipid emulsion drop in habitual contact lens wearers. Athira Rohit, Mark Willcox, Todd W Mitchell, Fiona Stapleton. Paper presentation at the Association of Research in Vision and Ophthalmology (ARVO), Denver, US, May 2015.
3.	Tear film lipids and contact lens comfort. Athira Rohit, Mark Willcox, Fiona Stapleton. Paper presentation at the Ocular Surface Science and Dry Eye conference, Sydney, Australia, July 2014.
4.	The effect of lipid supplementations on the tear film lipid layer of habitual soft contact lens wearers; an exploratory study. Athira Rohit, Mark Willcox, Todd Mitchell, Fiona Stapleton. Paper presentation at the Association of Research in Vision and Ophthalmology (ARVO), Orlando, US, May 2014.

Public notes

Contacts

Principal investigator

Name

Prof Fiona Stapleton

Address

School of Optometry and Vision Science
Level 3 North Wing Rupert Myers Building
Gate 14 Barker Street
University of New South Wales
Kensington, NSW, 2033

Country

Australia

Phone

+ 61 2 9385 5287

Fax

f.stapleton@unsw.edu.au

Contact person for public queries

Name

Athira Rohit

Address

Level 5 North Wing Rupert Myers Building
Gate 14 Barker Street
University of New South Wales
Kensington, NSW, 2033

Country

Australia

Phone

+61 2 9385 7420

Fax

a.rohit@unsw.edu.au

Contact person for scientific queries

Name

Athira Rohit

Address

Level 5 North Wing Rupert Myers Building
Gate 14 Barker Street
University of New South Wales
Kensington, NSW, 2033

Country

Australia

Phone

+61 2 9385 7420

Fax

a.rohit@unsw.edu.au

No information has been provided regarding IPD availability

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.

Trial Review

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